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Diss Factsheets

Administrative data

Description of key information

Skin irritation: The substance is not irritating to the skin of rabbits based on the results of a GLP study performed according to OECD TG 404.
Eye irritation: The substance is not irritating to the eyes of rabbits based on the results of a GLP study performed according to OECD TG 405.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-05-17 to 2007-05-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 2.88 - 2.94 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61 - 72°F
- Humidity (%): 30 - 70%
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12 hour light:dark cycle

IN-LIFE DATES: From: 2007-05-17 To: 2007-05-20
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
- Concentration (if solution): neat
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 female
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 2.5 cm2, 2-layer gauze patch held in place with non-irritating Kendall Curity Standard Porous tape and covered with semi-occulsive plastic overwrap again secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess material removed but washing not specified.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There were no skin reactions in any of the three test animals.
Other effects:
No other effects noted in any of the three animals
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material does not meet the criteria for classification as a skin irritant as defined in the EU CLP Regulation (EC) No. 1272/2008 under the conditions of the study.
Executive summary:

In a study performed to OECD Guideline 404 and US EPA OPPTS 870.2500, 0.5 mL of the neat test material was applied to a clipped test site on each of three New Zealand white rabbits (female) and covered with a 2 layer gauze patch secured with non-irritating Kendall Curity Standard Porus tape covered with a semiocclusive plastic overwrap secured with non-irritating Kendall Curity Standard Porus tape for 4 hours. After 4 hours the test sites were wiped with a damp cloth. The sites were examined for erythema and edema using Draize method of scoring at 4.5, 24, 48 and 72 hours.

Semi-occlusive 4 hour exposure to 0.5mL of the test material did not elicit any skin reaction at any of the observation points. No other test material effects were noted in the test animals.

The test material does not require classification for skin irritation according to EU the CLP Regulation 1272/2008.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-05-17 to 2007-05-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 2.55 - 2.73 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61 - 72°F
- Humidity (%): 30 - 70%
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12 hour light:dark cycle

IN-LIFE DATES: From: 2007-05-17 To: 2007-05-21
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye acted as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): neat

Duration of treatment / exposure:
72 hours (Eyes not washed)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4

Table 1: Individual irritation scores

Rabbit number

Cornea

Iris

Conjunctiva (redness)

Chemosis

24 h

48 h

72 h

24 h

48 h

72 h

24 h

48 h

72 h

24 h

48 h

72 h

650

0

0

0

0

0

0

1

0

0

0

0

0

651

0

0

0

0

0

0

0

0

0

0

0

0

652

0

0

0

0

0

0

1

0

0

0

0

0

Mean score

0.0

0.0

0.22

0.0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were minimal eye irritation reactions in all three animals. The maximum group mean score was 6.67/110.0 at the 1 hour observation. All reactions were fully reversible by the 48 hour observation. Under the conditions of the study the test material is not irritating to the eyes of rabbits.
Executive summary:

In a study performed to OECD Guideline No. 405 and US EPA OPPTS 870.2400 0.1 mL of the test material was applied as supplied to the non-irrigated eye of three female albino New Zealand rabbits. Irritation was recorded using the Draize scale at the 1, 24, 48 and 72 hour time points.

There were minor positive conjunctiva reactions in all of the test subjects at the 1 hour observation giving a maximum group mean score of 6.67/110.0. Effects were fully reversible by the 48 hour observation point.

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a study performed to OECD TG 404 and US EPA OPPTS 870.2500, 0.5 mL of the substance was applied to a clipped test site on each of three New Zealand white rabbits (female) and covered with a 2 layer gauze patch and a semiocclusive plastic overwrap. After 4 hours the test sites were wiped with a damp cloth. The sites were examined for erythema and edema using Draize method of scoring at 4.5, 24, 48 and 72 hours.

Semi-occlusive 4 hour exposure to 0.5mL of the test material did not elicit any skin reaction at any of the observation points. No other test material effects were noted in the test animals. The substance is not irritating to the skin of rabbits under the conditions of this test.

Eye irritation

In a study performed to OECD TG 405 and US EPA OPPTS 870.2400 0,.1 mL of the substance was applied as supplied to the non-irrigated eye of three female albino New Zealand rabbits. Irritation was recorded using the Draize scale at the 1, 24, 48 and 72 hour time points.There were minor positive conjunctiva reactions in all of the test subjects at the 1 hour observation giving a maximum group mean score of 6.67/110.0. Effects were fully reversible by the 48 hour observation point. The substance is not irritating to the eyes of rabbits under the conditions of this test.


Justification for selection of skin irritation / corrosion endpoint:
k=1 in vivo study performed on the substance itself

Justification for selection of eye irritation endpoint:
k=1 in vivo study performed on the substance itself

Justification for classification or non-classification

Skin irritation:

In a study performed according to OECD TG 404, no signs of erythema or edema were observed in any animal at any time point.

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.

Eye irritation:

In a study performed according to OECD TG 405, the mean of the 24, 48 and 72 -h scores for each rabbit was below the level required for classification. Furthermore, where effects were seen they were full reversible within 48 hours. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for eye irritation.