Registration Dossier

Administrative data

Description of key information

The irritation potential has been assessed to the skin and eye of rabbits

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 21 January 2002 and 18 March 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and GLP.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, PA
- Weight at study initiation: 2.9-3.1 kg
- Housing: 1 animal/cage in suspended wire cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/rabbit
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: plastic


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, 48h, and 72 h for each animal.
Other effects:
Animals did not display any abnormal signs throughout the test period. Bodyweights did not significantly alter.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Score at time point / Reversibility

Erythema

Oedema

Max. score: 4

Max. score: 2

60 min

1/0/1

 0/0/1

24 h

1/0/1

 0/0/1

48 h

1/0/2

 0/0/1

72 h

0/0/2

 0/0/1

Average 24h, 48h, 72h

 0.7/1/0.7

 0.3/0.3/0.3

Reversibility*)

 c/c/c

 c/c/c

Average time (unit) for reversion

 72/0/14d

 0/0/14d

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is determined to be non-irritating.
Executive summary:

In a primary dermal irritation study , 3 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts for 4 hours.  Animals then were observed for 14 days.  Irritation was scored by the method of Draize.

 

In this study, Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts is not a dermal irritant.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
STUDY INITIATED ON April 29,1999 STUDY COMPLETED ON August 16,1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Source: Covance Research Products, Inc., Denver, PA

Number: Three males and three females

Body Weight Range: 2370 to 3328 grams at initiation of dosing
Age at Start of Study: Young adult
Method of Identification: Eartag

Housing: Individual suspended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc. in
accordance with standard operating procedures.

Acclimation: The animals were acclimated to laboratory conditions for a minimum of seven days prior to initiation of dosing.

Food and Water: PMI Nutrition International, Inc. Certified Rabbit LabDiet 5322 was offered at approximately 150 g per day during the study. Analysis of feed was performed and provided by the manufacturer. Reverse osmosis-treated municipal water was provided ad libitum. Water was analyzed in accordance with standard operating procedures. Contaminants were not present in animal feed or water at levels expected to interfere with the objective of this study. Results of analyses are available upon sponsor request.
Environmental Conditions: Animal room with controlled temperature (64.1- 67.2°F), humidity (50.1-76.7%) and light (12 hours light/l2 hours dark). The humidity was slightly above the protocol-specified range (30-70%) within the study period. A brief period of slightly increased humidity would not be expected to adversely affect the health of the rabbits. Therefore, this deviation did not affect the quality or integrity of the study.
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The dosage level was 0.5 ml/site
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
Test Article Preparation:
Prior to use, the original container of the test article was agitated to insure a homogeneous mixture. A sufficient amount of test article was dispensed and a stir bar was added. The test article was stirred continuously throughout use.

Route and Rationale of Test Article Administration:
The route of administration for the test article was direct application to clipped, unabraded skin. This route of administration is standard for assessment of local dermal irritative potential.

Method of Test Article Administration:
On the day prior to dosing, the hair was removed from the backs and flanks of the rabbits using an electric clipper. Each 0.5-ml dose was applied to an area of skin approximately 2.5 x 2.5 cm under a two-ply gauze patch secured in place with Micropore tape. The patches were overwrapped with a gauze binder and secured with Dermiform tape. Plastic restraint collars were applied to the animals to prevent ingestion of the test article andor bandages.
Irritation parameter:
other:
Basis:
animal: 28361 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours, 4 - 13 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: Yellow staining at test site at 1 and 24 hours.
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 28364 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours, 4 - 13 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: Yellow staining at test site at 1 and 24 hours. Desquamation at 7 - 13 days
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 28466 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Yellow staining at test site at 1, 24 and 48 hours
Irritation parameter:
other: Erythema/Eschar
Basis:
animal: 28474 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no evidence of skin irritation
Remarks on result:
other: Yellow staining at test site at 1, 24, 48 and 72 hours
Irritation parameter:
other: Erythema/Eschar
Basis:
animal: 28749 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Yellow staining at test site at 1, 24 and 48 hours
Irritation parameter:
other: Erythema/Eschar
Basis:
animal: 28482 female
Time point:
other: Highest score at 1, 24, 48, 72 hours and 4 - 8 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Yellow staining at test sites at 1, 24 and 48 hours
Irritation parameter:
other: Oedema Formation
Basis:
animal: 28361 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours and 4 - 13 days
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
other: Oedema Formation
Basis:
animal: 28364 male
Time point:
other: Highest score at 24, 48 and 72 hour, 4 - 13 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 13 days
Irritation parameter:
other: Oedema Formation
Basis:
animal: 28466 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
other: Oedema formation
Basis:
animal: 28474 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no evidence of skin irritation
Irritation parameter:
other: Oedema formation
Basis:
animal: 28749 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no evidence of skin irritation
Irritation parameter:
other: Oedema formation
Basis:
animal: 28482 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours, 4 - 8 days
Score:
0
Max. score:
4
Reversibility:
other: no evidence of skin irritation
Irritant / corrosive response data:
Mortality:
There were no deaths during the study.

Dermal Observations (Table 1 - attachment 1):
The test article induced very slight to slight erythema and very slight edema on five and one animals, respectively. Desquamation and yellow staining of the skin were noted for one and six rats, respectively.There were no other signs of dermal irritation noted during the study. All dermal irritation completely subsided by day 13.

Body Weiphts (Table 2 - attachment 2):
There were no remarkable body weight changes during the study period.
Interpretation of results:
slightly irritating
Remarks:
Migrated information The test article, OS65841C, received a descriptive rating classification of slightly irritating. Criteria used for interpretation of results: other: Draize JH 1965
Conclusions:
There were no deaths or remarkable body weight changes during the study period.
The test article induced very slight to slight erythema and very slight edema on five and one animals, respectively. Desquamation and yellow staining of the skin were noted for one and six rats, respectively. There were no other signs of dermal imtation noted during the study. All dermal imtation completely subsided by day 13.
The Primary Irritation Index was calculated to be 0.5. The test article, OS65841C, received a descriptive rating classification of slightly irritating.
Executive summary:

The primary dermal irritation potential of OS65841C was evaluated in this study with New Zealand White rabbits.

There was one group of six albino rabbits that received a single, four-hour, semioccluded exposure.

Each 0.5-ml dose of the test article was applied to the clipped, unabraded skin. At completion of exposure, the bandages were removed and the sites washed.

Application sites were evaluated in accordance with the method of Draize (attachment 3) at approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and daily through day 13, if irritation persisted.

The test article induced very slight to slight erythema and very slight edema on five and one animals, respectively. Desquamation and yellow staining of the skin were noted for one and six rats, respectively. There were no other signs of dermal irritation noted during the study. All dermal irritation completely subsided by day 13.

The test article, OS65841C, received a descriptive rating classification of slightly irritating.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 22 September and 5 October 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, OECD Guidelines and to GLP standards, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Young adult animals weighing 3209 to 3587 grams at initiation of dosing were identified by eartag and housed in individual suspended wire mesh cages. The animals were acclimated to laboratory conditions for a minimum of seven days prior to dosing. They were provided PMI Nutrition International, Inc Certified Rabbit LabDiet(R) 5322 feed (approx. 150g/day) during the study and Municipal water ad libitum. Environmental conditions were controlled: 68.2-69.1 deg F, 35.8 to 64.1 % humidity and 12 hours light/12 hour dark cycles.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
13 days
Number of animals:
6
Details on study design:
A group of 6 animals were acclimated for a minimum of 7 days. A dose of 0.5 ml then was applied to a shaved, unabraded site on each animal. A semi-occlusive wrapping was applied to hold the test material in place. At the end of a 4 hours, the wrapping was removed and the site was wiped with a disposable towel moistened with deionized water to remove the test material. The test sites were then evaluated in accordance with the method of Draize at approximately 30-60 minutes, 24, 48 and 72 hours and daily through day 13 if irritation persisted. Animals were observed twice daily for mortality, and body weights were recorded at day 0 and termination.
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 24 hours
Score:
1.83
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 48 Hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 72 Hours
Score:
1.83
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 24 Hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(Initact skin)
Basis:
mean
Time point:
other: 48 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 72 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Other effects:
No mortality or effects on body weight were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008 this substance is not classified as a skin irritant.
Executive summary:

A group of 6 animals were acclimated for a minimum of 7 days. A dose of 0.5 ml then was applied to a shaved, unabraded site on each animal using OECD Guideline 404. A semi-occlusive wrapping was applied to hold the test material in place. At the end of a 4 hours, the wrapping was removed and the site was wiped with a disposable towel moistened with deionized water to remove the test material. The test sites were then evaluated in accordance with the method of Draize at approximately 30-60 minutes, 24, 48 and 72 hours and daily through day 13 if irritation persisted. Mean erythema scores at 24, 48 and 72 hours were 1.83, 1.67, and 1.83, respectively and were fully reversible by day 13. Mean edema scores at 24, 48 and 72 hours were 0.17, 0, and 0, respectively and were fully reversible by 48 hours. No mortality or effects on body weight were observed. Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 14 October 1999 and 23 October 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2141 to 2331 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): Certified Rabbit Lab diet 150 g/day
- Water (e.g. ad libitum): as libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 30.2 - 48.5%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
Eyelids of animals were held closed for one second after installation.
Observation period (in vivo):
1, 24, 48 and 72 hours following dosing and on day 4.
Number of animals or in vitro replicates:
3 male/3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed exposure

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: ophthalmoscope/ fluorescein
Irritation parameter:
cornea opacity score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
Animals 2 and 3 and 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Animals 4 and 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
Animals 4 and 5
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Other effects:
One animal had clear discharge from the eye, one hour post dosing. There were no deaths or changes in bodyweight throughout the study.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for conjuntival redness and oedema were less than 2 in all animals. Therefore, this substance is not irritating to rabbit eyes.
Executive summary:

In a primary eye irritation study 0.1 ml of substance was instilled into the conjunctival sac of young adultwhite rabbits (3/sex).  Animals then were observed for 7 days. Irritation was scored by the method of Draize.

 

No eye irritation was observed.  In this study, substance is not an eye irritant.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 09 February 1981 and 16 February 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
equivalent or similar to
Guideline:
other: Section 1500.42 Federal Hazardous Substances Act Regulations - CFR 16 P. 125.
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Six healthy young adult albino rabbits were used in this study.
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:
0.1 gm of the experimental material was instilled into the right eye.
Duration of treatment / exposure:
The test material was not washed from the eyes.
Observation period (in vivo):
The treated eyes were examined at one, two, three, five and seven days following instillation of the test material into the eyes.
Number of animals or in vitro replicates:
6
Details on study design:
Six healthy young adult albino rabbits were used in this study.
0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes.
The treated eyes were examined at one, two, three, five and seven days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions - see attachment 1
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 1
Score:
0
Max. score:
110
Reversibility:
other: No effects observed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 2
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks:
No effects observed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 3
Score:
0
Max. score:
110
Reversibility:
other: No effects observed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 5
Score:
0
Max. score:
110
Reversibility:
other: No effects observed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 7
Score:
0
Max. score:
110
Reversibility:
other: No effects observed
Irritant / corrosive response data:
Based on the accompanying table, the subject material is not a primary irritant within the definition of the Act Reference Section 1500.42 (b) (1) (2), and requires no cautionary labeling with respect to that section.

See Table 1 - attachment 2

See Table 1 - attachment 2

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Based on the accompanying table, the subject material is not a primary irritant within the definition of the Act Reference Section 1500.42 (b) (1) (2), and requires no cautionary labeling with respect to that section.
Conclusions:
Based on the accompanying table, the subject material is not a primary irritant within the definition of the Act Reference Section 1500.42 (b) (1) (2), and requires no cautionary labeling with respect to that section.
Executive summary:

To determine the degree of irritation,if any, which the subject material may produce when instilled into the eyes of albino rabbits.

Six healthy young adult albino rabbits were used in this study. 0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at one, two, three, five and seven days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions.

Based on the accompanying table, the subject material is not a primary irritant within the definition of the Act Reference Section 1500.42 (b) (1) (2), and requires no cautionary labeling with respect to that section.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 7 October 1999 and 16 October 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols/ OECD Guideline and to GLP standards, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult animals weighing 2222 to 2515 grams were identified with eartags. the animals were housed in individual suspended wire mesh cages and acclimated for a minimum of 7 days. They were offered approximately 150 g of PMI Nutrition International inc. Certified Rabbit LabDiet(R) 5322 per day and given Municipla water ad libitum. Animal rooms were controlled at 68.3-68.8 deg F, 30.2-55.0% rhumidity and 12 hour light/12 hour dark cycles.
Controls:
other: One eye was use for the test substance; the other served as the control.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
1, 24, 48, 72 hours and day 4 when no irritation was observed
Number of animals or in vitro replicates:
6
Details on study design:
A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 ml of the test article instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control. Mortality checks were conducted twice daily and body weights were recorded at day 0 and termination. Animals were observed at 1, 24, 48, 72 hours and through day 4 for eye irritation in accordance with the method of Draize.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 Hours
Score:
0
Max. score:
4
Reversibility:
other: No corneal effects noted
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 Hours
Score:
0
Max. score:
2
Reversibility:
other: No iridial effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 Hours
Score:
0.95
Max. score:
3
Reversibility:
fully reversible within: day 4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 Hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Other effects:
No mortality or effects on body weight were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008 this substance is not classified as an eye irritant.
Executive summary:

The eye irritation potential of OS 84147H was evaluated in accordance with OECD Guidline 405. A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 ml of the test article instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control. Mortality checks were conducted twice daily and body weights were recorded at day 0 and termination. Animals were observed at 1, 24, 48, 72 hours and through day 4 for eye irritation in accordance with the method of Draize. No mortality or effects on body weight were observed. Mean 24, 48, and 72 hour corneal, iris and conjunctival erythema and chemosis scores were 0, 0, 0.95 and 0.33, respectively. Based on these results this substance is not classified as an eye irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

All available skin irritation and eye irritation data available demonstrate that the substance tested was not irritanting to skin or eyes.

Data are presented only using in vivo methods as these data were available for the substance. In vitro data are considered not justifiable scientifically or by expense as the data are not likely to provide any additional contribution to the conclusion available from the in vivo data.

Justification for classification or non-classification

Based on the data available for skin and eye irritation, exposure to the substance gives rise to no adverse reactions. The substance is, therefore, considered to be not irritating to skin or eyes.