Registration Dossier

Administrative data

Description of key information

The amine component is not irritating to the skin (Hüls 1981) and irritating to the eyes (Hüls 1985). Tests are available on skin and eye irritation in the rabbit (OECD 404 and 405 respectively).

Tests with the acid and its sodium salts are available. The acid is a severe skin irritant (corrosive)(1980), while the sodium salt is irritating to the skin (1986). For eye irritation the acid shows moderate eye irritation in the rabbit eye (1984), while the sodium salt which is most comparable to the salt assessed shows severe eye irritation (1986). An eye irritation study using the compound shows severe eye irritation (2017).

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
Remarks:
the tested substance is the acid part of the compound
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to
Guideline:
other: Draize Test 1965
Principles of method if other than guideline:
The test material was applied as submitted to the intact skin and covered with a "1 x 1" gauze patch held in place with saran wrap. At the end of 4 hours, the coverings were removed and the area examined for skin irritation and corrosion. Examinations were repeated at 24 and 48 hours and scored according to Draize 1965.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Male and female white New Zealand rabbits weight between 4 and 5.6 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Observations were made after 4, 24, and 48 hours,
Number of animals:
6 (3 male, 3 female)
Details on study design:
The test material was applied as submitted to the intact skin and covered with a "1 x 1" gauze patch held in place with saran wrap. At the end of 4 hours, the coverings were removed and the area examined for skin irritation and corrosion. Examinations were repeated at 24 and 48 hours and scored according to Draize 1965.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4 hours
Score:
3.4
Reversibility:
not reversible
Remarks on result:
other: highly irritating
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
6.3
Reversibility:
not reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 hours
Score:
7
Reversibility:
not reversible
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Result: corrosive
EC Classification: irritating at 0.5 mL
Executive summary:

The test material was applied as submitted to the intact skin and covered with a "1 x 1" gauze patch held in place with saran wrap. At the end of 4 hours, the coverings were removed and the area examined for skin irritation and corrosion. Examinations were repeated at 24 and 48 hours and scored according to Draize 1965 The primary dermal irritation scores were 3.4, 6.3, and 7.0 at 4, 24, and 48 hours, respectively.

The test substance is considered corrosive to skin according to OECD GHS guidelines.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Remarks:
the tested substance is the acid part of the compound
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment tested on 47% formulation
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: New Zealand albino rabbits
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits and Buckmasters
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.7-3.3 kg
- Housing: individually housed in metal cages, identified by aluminum ear tags
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation: yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 degree C
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: March 18, 1986 To: March 31, 1986
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 ml aliquot of P-500 N-Na
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
Hair was clipped from a 10 x 10 area of the dorsal-lumbar region. Test substance was applied under a gauze pad, and then covered with elastic adhesive dressing. Examination of the treated skin was made approximately 30 minutes after removal of the patch and daily through 14 days. Grading and scoring of the dermal reactions was performed using the standard numerical scoring system.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
2.17
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
Well defined to moderate skin reactions were observed in all three animals following removal of the bandages. Desquamation of the stratum corneum was observed in all three animals. The reaction in all three animals gradually ameliorated from Days 5, 10 and 11, respectively, and had all resolved completely in one animal by Day 12.

Results of Skin Irritation Study

Day

Animal

1417

1491

1726

Erythema

Edema

Erythema

Edema

Erythema

Edema

0

2

1

2

2

2

1

1

2

2

2

3

2

3

2

2

2

2

1

2

2B

3

4

2A

2

1C

2

3B

4

4

2A

1

1C

2

3B

5

4

2A

1

1C

2

3B

6

4

3A

1

1C

2

3B

7

4

3A

1

1C

2

2B

8

4A

3C

1

1C

2

2B

9

2

2

1

1C

2B

2B

10

1

2

1

0

1

2

11

1

1

0

0

1

2

12

1

1

-

-

1

0

13

1

1

-

-

1

0

A - Necrosis B -Hyperkeratinization C - Desquamation

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substance was moderately to severely irritating to skin, but effects were not fully reversible within 14 days. The test substance is a Category 2 irritant according to EU GHS guidelines based on persistent irritation.
Executive summary:

This study was performed on three animals with a semi-occlusive application, according to the OECD Guideline 404 and GLP. LAS concentration as active matter was 47%. Three rabbits were exposed to 0.5 ml of the test substance dermally for 4 hours on clipped skin under a gauze pad held in place by an adhesive dressing. Examination of the treated skin was made approximately 30 minutes after removal of the patch and daily through 14 days. Grading and scoring of the dermal reactions was performed using the standard numerical scoring system. Irritation was noted in all animals at the first observation (maximum score of 2). Symptoms worsened, and desquamation, necrosis, and hyperkeratinization was noted by day 4. Symptoms resolved in one animal by day 12, but in the other two animals, symptoms were seen through the end of the observation period. The primary dermal irritation index was 2.17. The test substance is considered a Category 2 irritant according to EU GHS guidelines based on persistent irritation.

 

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Remarks:
the tested substance is the amine part of the compound
Adequacy of study:
key study
Study period:
20. Sep 1981 - 23. Sep 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: small white russians, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Dr. Karl Thomae GmbH, Biberach, Germany- Weight at study initiation: 2.2 - 2.7 kg- Housing: single cages- Diet: K4 Alleindiaet für Kaninchen (Ssniff Spezialfutter GmbH, 4770 Soest) ad libitum- Water: tap water ad libitum- Acclimation period: 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20°C ± 1°C- Humidity (%): 60 ± 5 %- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE- Area of exposure: approx. 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals- Type of wrap if used: mull patch (2,5 x 2,5 cm) covered with a polyethylen film (6 x 6 cm) and secured by an elastic bandageREMOVAL OF TEST SUBSTANCE- Washing (if done): with warm water- Time after start of exposure: 4 hoursSCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.06
Max. score:
8
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 -72 h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms observed

Mean erythema and edema scores animal 1 - 6:

    1 h      24 h    48 h        72 h
  Erythema   Edema  Erythema  Edema  Erythema  Edema Erythema Edema
Animal 1  1  0  0  0  0  0 0 0
Animal 2  1  0  1  0  0  0  0
 Animal 3  0  0  0  0  0  0  0
 Animal 4 1  0  0  0  0  0  0 0
 Animal 5  1  0  0  0  0  0  0  0
 Animal 6  0 0  0  0  0  0  0
 mean:  0.16  0  0.16  0  0  0  0  0

Mean erythema score (24 - 48 -72 h): 0.06

Mean edema score (24 - 48 - 72 h): 0

The application of the test substance caused only slight erythema in 4/6 animals after 1 h and was fully reversible within 48 h.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
other: the tested substance is the acid part of the compound
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male and female white New Zealand rabbits weight between 3.7 and 6.0 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single treatment that was not washed out.
Observation period (in vivo):
1, 24, 48, and 72 hours and at 6 days after application.
Number of animals or in vitro replicates:
6 (3 male, 3 female)
Details on study design:
Treatment was to the right eye with lower lid removed. The left eye was untreated and served as the control. The eyes were not washed out during the test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, and 72 hrs and 6 days
Score:
46.9
Reversibility:
not fully reversible within: 6 days
Remarks on result:
other: moderately irritating
Irritant / corrosive response data:
Results indicated a moderate irritancy, but because of the intensity of the necrosis formation, the study was stopped at day 6.

Treatment was to the right eye with lower lid removed. The left eye was untreated. The eyes were not washed out duringthe test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application. The total irritation index was 46.9.

Interpretation of results:
moderately irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Result: moderately irritating at 0.1 mL.
Executive summary:

The eyes of six rabbits were treated with the test substance and observed for six days. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6.

Endpoint:
eye irritation: in vivo
Type of information:
other: the tested substance is the acid part of the compound
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment, 47% formulation tested
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: New Zealand albino rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits and Buckmasters
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.1-3.1 kg
- Housing: individually housed in metal cages, identified by aluminum ear tags
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation: yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 degree C
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: March 24, 1986 To: May 12, 1986
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL aliquot of P-500 N-Na
Duration of treatment / exposure:
For three rabbits the eyelids were then gently held together for one second before releasing.
For three other rabbits the eyes were irrigated with water for 5 minutes following a 4-second exposure.
For the remaining three rabbits the eyes were irrigated for 5 minutes following a 30-second exposure.
Observation period (in vivo):
Eyes were examined after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after exposure.
Number of animals or in vitro replicates:
9
Details on study design:
Nine rabbits received a 0.1 mL aliquot of P-500 N-Na placed into the lower everted lid of one eye per animal. For three rabbits the eyelids were then gently held together for one second before releasing. For three other rabbits the eyes were irrigated with water for 5 minutes following a 4-second exposure. For the remaining three rabbits the eyes were irrigated for 5 minutes following a 30-second exposure. Eyes were examined after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after exposure. Grading was performed using the standard scoring system.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
1.75
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: not rinsed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinse after 4 seconds
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
1.06
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: rinsed after 30 seconds
Irritant / corrosive response data:
The following results were noted:
1) Three animals without any rinsing: averaged irritation scores (24, 48, 72 hours) for each animal: cornea 2.3, 1.7, 2; iris: 1.3, 0, 0; conjunctivae redness: 3, 1.7, 2; conjunctivae chemosis: 3, 2, 2. In the first animal the effects were persistent at day 14.

2) Three animals with rinsing for five minutes following a 30 second exposure: averaged scores: cornea 0.7, 1, 1.3; iris: 0, 0.7, 0.3; conjunctivae redness: 1.7, 2, 1.3; conjunctivae chemosis: 2, 1.3, 2. The eyes were normal 7 or 14 days after instillation.

3) Three animals with rinsing for five minutes following a 4 second exposure: averaged scores: cornea 0.7, 2.3, 0.7; iris: 0, 0, 0; conjunctivae redness: 1.7, 1.7, 1; conjunctivae chemosis: 1.3, 2, 1. The eyes were normal 7 days after instillation.

Findings lead to a definition of irritating for LAS at 47% applied without rinsing, irritating (even if with lower effects, mainly as cornea opacity and conjunctivae redness) with rinsing after 30 second of exposure, and not irritating with rinsing after 4 second of exposure.

Overall, instillation of P-500 N-Na into the eyes of rabbits elicited positive responses in all animals. Irrigation of the eyes only slightly reduced the irritation potential.

Results of Eye Irritation Study,No Rinsing

 

 

Hours

Days

Animal

 

1

24

48

72

4

7

14

21

1

Cornea

2

1

2

4

3B

3B

3BC

3BC

Iris

0

1

1

2

1

1

1

0

Conjunctiva - Erythema

1

3

3

3

3

3

2

1

Conjunctiva,Chemosis

2

3

3

3

3

2

2

1

2

Cornea

1

1

2

2

2

1

0

 

Iris

0

0

0

0

0

0

0

 

Conjunctiva - Erythema

1

1

2

2

1

0

0

 

Conjunctiva ¿ Chemosis

1

2

2

2

1

0

0

 

3

Cornea

1

2

2

2

2

1

0

 

Iris

0

0

0

0

1

0

0

 

Conjunctiva - Erythema

1

2

2

2

2

1

0

 

Conjunctiva,Chemosis

1

2

2

2

2

0

0

 

Results of Eye Irritation Study,Rinsing after 4 Seconds

 

 

Hours

Days

Animal

 

1

24

48

72

4

7

1

Cornea

0

0

1

1

1

0

Iris

0

0

0

0

1

0

Conjunctiva - Erythema

1

2

2

1

2

0

Conjunctiva,Chemosis

2

2

1

1

1

0

2

Cornea

0

2

3

2

0

0

Iris

0

0

0

0

0

0

Conjunctiva - Erythema

1

2

2

1

2

0

Conjunctiva,Chemosis

2

2

2

1

1

0

3

Cornea

0

1

0

1

1

0

Iris

0

0

0

0

0

0

Conjunctiva - Erythema

1

1

1

1

2

0

Conjunctiva,Chemosis

2

1

1

1

1

0

Results of Eye Irritation Study,Rinsing after 30 Seconds

 

 

Hours

Days

Animal

 

1

24

48

72

4

7

14

1

Cornea

0

1

0

D

D

1

0

Iris

0

0

0

0

0

0

0

Conjunctiva - Erythema

1

2

2

1

1

1

0

Conjunctiva,Chemosis

2

1

1

0

0

0

0

2

Cornea

0

1

1

1

2

0

 

Iris

0

0

1

1

0

0

 

Conjunctiva - Erythema

1

2

2

2

2

0

 

Conjunctiva,Chemosis

2

1

2

1

1

0

 

3

Cornea

0

1

2

1

2A

2AB

0

Iris

0

0

0

1

1

1

0

Conjunctiva - Erythema

1

1

1

2

2

2

0

Conjunctiva,Chemosis

2

2

2

2

1

1

0

A Loss of Corneal Epithelium

B Vascularization

C Pannus

D Dulling of the Cornea

 

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Result: irritating at 0.1 mL.
Executive summary:

This study, performed according to OECD Guidelines, was conducted on three rabbits with LAS at 47%. Groups of three rabbits had 0.1 ml of test substance placed in each of their eyes. In one group, the eyes were not rinsed. In the second group, the eyes were rinsed after 4 seconds of exposure. In the third group, the eyes were rinsed after 30 seconds of exposure. Observations were made one hour and 1, 2, 3, 4, 7, 14, and 21 days after exposure. Severe irritation was noted in the animals whose eyes were not rinsed. This irritation was not resolved in one of these animals at the end of 21 days. Irritation was also seen in the animals rinsed after 30 seconds, although the irritation was not as severe, and the effects were fully reversible within 14 days. Mild irritation was seen in the animals rinsed after 4 seconds. These effects were fully reversible within 7 days. Since OECD guideline 405 for eye irritation studies calls for an exposure of at least 24 hrs, the results for unrinsed eyes were used for classification. According to these results, the test substance is a category 1 eye irritant because it caused damage that was not reversible within 21 days.

 

 

 

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Remarks:
the tested substance is the amine part of the compound
Adequacy of study:
key study
Study period:
20. Sep 1985 - 11. Oct 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: short white russians Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Dr . Karl Thomae GmbH, Biberach, Germany- Weight at study initiation: 2.3 - 2.4 kg- Housing: single cages- Diet (e.g. ad libitum): K4 Alleinfutter für Kaninchen ad libitum (Ssniff Spezialfutter GmbH, 4770 Soest).- Water: tap water ad libitum- Acclimation period: 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20°C ± 1°C- Humidity (%): 60% ± 5%- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
72 h
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): with warm phyiological saline- Time after start of exposure: 72 hoursSCORING SYSTEM: according to Draize (Appraisals of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin 1, Texas 1959, page 51)TOOL USED TO ASSESS SCORE: sodium fluorescein solution, no more data
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversible in all but one animal within 17 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
0.4
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversible in all but one animal within 12 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversible in all but one animal within 12 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
1.1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversible in all but one animal within 10 days
Irritant / corrosive response data:
The test substance caused irreversible effects to the exposed eyes predominantly expressed by heavy erythema, iritis (3/6), opacity and chemosis. Five animals showed bleeding of the mucous membrane. In four animals occured circum-corneal injections after 7 days and in 1 animal circum-corneal injections and eye reactions were not fully reversible within the observation period of 21 days.

Findings: animal 1 - 6:

Animal 1/2/3/4/5/6  1 h  24 h  48 h  72 h  14 days          
A) corneal opacity 1/1/1/1/1/1 1/1/2/1/1/1 1/1/1/1/1/2 1/2/2/2/2/2 0/1/0/2/0/0          
B) area 3/3/3/4/4/3 4/3/2/4/4/4 2/3/2/4/4/4 2/3/2/3/2/3 0/1/0/2/0/0          
a = AxBx5 15/15/15/20/20/15 20/15/20/20/20/20 10/15/10/15/10/30 10/30/30/30/20/30 0/5/0/20/0/0          
                     
Iris 0/0/0/0/0/0 1/0/0/1/1/0 1/0/0/0/1/0 0/1/0/1/1/0 0/0/0/0/1/0          
b = Ax5 0/0/0/0/0/0 5/0/0/5/5/0 5/0/0/0/5/0 0/5/0/5/5/0 0/0/0/0/5/0          
                     
Conjunctiva                    
A) erythema 3/3/3/3/3/3 3/3/3/3/3/3 3/3/3/3/3/3 3/3/3/3/3/3 0/0/0/3/0/0          
B) chemosis 1/2/2/2/2/2 1/2/1/1/1/1 1/1/1/1/1/1 0/1/1/2/1/1 0/0/0/1/0/0          
C) secretion 2/3/3/2/3/3 1/2/2/1/2/2 2/1/2/2/2/2 0/2/2/0/0/1 0/0/0/0/0/0          

c = (A+B+C)x2

12/16/16/14/16/16 10/14/12/12/12/12 12/10/12/12/12/12 6/12/12/10/8/10 0/0/0/8/0/0          

Mean values over 24, 48, and 72 h (OECD score):

Animal 1: Opacity: 1; Iritis: 0.6; Erythema: 3; Chemosis: 0.6

Animal 2: Opacity: 1.3; Iritis: 0.3; Erythema: 3; Chemosis: 1.3

Animal 3: Opacity: 1.7; Iritis: 0; Erythema: 3; Chemosis: 1.7

Animal 4: Opacity: 1.3; Iritis: 0.6; Erythema: 3; Chemosis: 1.3

Animal 5: Opacity: 1.3; Iritis: 1; Erythema: 3; Chemosis: 1.3

Animal 6: Opacity: 1.7; Iritis: 0; Erythema: 3; Chemosis: 1.7

The test substance caused irreversible effects to the exposed eyes predominantly expressed by heavy erythema, iritis (3/6), opacity and chemosis. Five animals showed bleeding of the mucous membrane. In four animals occured circum-corneal injections after 7 days and in 1 animal circum-corneal injections and eye reactions were not fully reversible within the observation period of 21 days.

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the information on the amine and the sodium salt of the acid the compound is considered irritating to the skin and severely irritant to the eyes. The sodium salt of the acid is expected to represent the local effects of the salt more accurately than does the acid.

Justification for classification or non-classification

Based on the study results on the components, the compound is considered irritant to the skin and severely irritating to the eyes. According to CLP (Regulation EC No 1272/2008) the substance needs to be classified as H315 (category 2: Causes skin irritation) and H318 (category 1: Causes serious eye damage)