Dodecylbenzenesulphonic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)

Endpoint summary

Description of key information

The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of DDBSA and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits. The test substance is considered corrosive to skin according to OECD GHS guidelines.

A study according to the OECD Guideline 404 was performed on the sodium salt of LAS. 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.

 

AMP was shown to cause skin irritation after repeated and single dermal exposure of rabbits.

Groups of three rabbits had 0.1 ml of DDBSA placed in each of their eyes (with and without rinsing). 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. An additional study was terminated after 6 days, because of the necrosis observed. DDBSA is considered to be severely iritating to the eyes.

In two studies of the eye irritation potential of AMP in rabbits, AMP was applied to the eyes of 6 rabbits (Strain and sex not recorded). In one study, the eyes were flushed with water 15 to 30 seconds post application, in the second study the eyes were not flushed with water. AMP caused severe damage to the eyes and flushing almost immediately with water appeared to have little beneficial effect. The Damage caused by AMP appears likely to be due to the high pH rather than any other type of chemical damage.

 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Remarks:

the tested substance is DDBSA one of the components 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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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:

occlusive

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 1, 24, 48, 72 hours and 6, 9, and 14 days.

Number of animals:

6 (3 male, 3 female)

Details on study design:

The shaved treated area (about 6 m2) was covered with gauze and covered by polyethylene film for the first 4 hours, at which time the test area was rinsed with warm water. Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Mean of 1, 24, 48 and 72 hours.

Score:

5.25

Max. score:

6

Reversibility:

not reversible

Remarks on result:

other: highly irritating

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48, 72 hr readings

Score:

5.33

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Other effects:

Significant reddening effects were observed at all times and were persistent. Bloody wounds and scar formation were observed through at least observation day 9.

Results of Skin Irritation Study in Rabbits

 

Observation	Endpoint	Male 11499	Male 11887	Male 11901	Female 11580	Female 11658	Female 11802
1 hr	Erythema	4 X	4 X	4 X	4 X	4 X	4 X
1 hr	Edema	1	1	1	1	1	1
24 hrs	Erythema	4 X	4 X	4 X	4 X	4 X	4 X
24 hrs	Edema	1	1	1	1	1	1
48 hrs	Erythema	4 X	4 X	4 X	4 X *	4 X	4 X *
48 hrs	Edema	1	1	1	1	1	1
72 hrs	Erythema	4 *	4 *	4 X *	4 X *	4 *	4 *
72 hrs	Edema	2	2	2	2	2	2
6 days	Erythema	4 +	4 *	4 *	4 * -	4 +	4 + -
6 days	Edema	2	2	2	2	2	2
9 days	Erythema	W	W	W	+	W	+
9 days	Edema	C N	C N	N		N	W
14 days	Erythema	N	N	N	N	N	N
14 days	Edema	N	N	N	N	N	N

X ¿ Necrosis in application area bordered by swelling

* - Application area hardened

+ - Wavy crust

- - Application area paper-like

W ¿ Bloody wounds

C - Crust formation

N ¿ Scar formation

 

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Result: Highly irritating at 0.5 mL

Executive summary:

The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of the test substance and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits. The test substance is considered corrosive to skin according to OECD GHS guidelines.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Remarks:

the tested substance is the sodium salt of DDBSA one of the components 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 tested on 47% formulation

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

other: New Zealand albino rabbits

Details on test animals or test system 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.

 

Reference 3

Endpoint:

skin irritation / corrosion, other

Remarks:

In vivo study preformed for this endpoint prior to perfection of in vitro assays. Data obtained from this study is considered accurate for determination of lack of corrosivity

Type of information:

experimental study

Remarks:

the tested substance is AMP one of the components of the compound

Adequacy of study:

supporting study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Methodology used was similar to guideline, no indication of GLP but reporting sufficient to assess the endpoint

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Deviations:

yes

Remarks:

The rabbit skin was evaluated only after four hours of exposure.

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

Conducted prior to GLP

Species:

rabbit

Strain:

other: Albino (no other data given)

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of test material as received

Duration of treatment / exposure:

4 hours

Observation period:

immediately after removal of occlusive dressing

Number of animals:

6

Irritation parameter:

other: Corrosion

Basis:

mean

Time point:

other: 4 hours

Remarks on result:

other: Not Corrosive

Only the corrosivity was determined, as such no information is provided on individual animal scores for erythema and edema. The conclusion of the assay was that the materials tested were not corrosive. No information is given on the irritancy of the material under the test circumstances.

Interpretation of results:

study cannot be used for classification

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

AMP-95 and AMP regular are consided non-corrosive.

Executive summary:

The skin corrosion potential of 2-amino-2-methyl-1-propanol (AMP) was studied extensively in 1975 when the US

Department of Transportation "harmonized" its classification criteria with those recommended by the UN experts.

At that time GLP requirements had not been established so the procedure in the Pharmacology Laboratory of

Commercial Solvents Corporation was to provide results on one-page Bioassay forms.

Because these tests at 4 hours exposure demonstrate that AMP is not corrosive, it is not necessary to redo the studies

with the modern protocol that protocol is designed to refine the hazard of corrosive materials for the assignment of

packing groups.

Reference 4

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo study

Type of information:

experimental study

Remarks:

the tested substance is AMP one of the components of the compound

Adequacy of study:

weight of evidence

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific standards, and acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline followed

Principles of method if other than guideline:

5 daily applications of test material to the shaved abdomen of rabbits.

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: supplier of animals not indicated, however all animals were sourced from a single supplier- Age at study initiation: All animals indicated to be 'young and healthy' nof urther information is given- Weight at study initiation: no data is given- Housing: Animals housed individually in cages - Diet (e.g. ad libitum): standard diet provided ad libitum throughout the study- Water (e.g. ad libitum): ad libitum water- Acclimation period: no details givem

Type of coverage:

open

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

The paper indicates a 'measured' amount of test material was applied to the skin, however no further details are given

Duration of treatment / exposure:

The exposures were conducted daily for 5 days. The duration of the exposure was dependant upon the time until the test site appeared 'dry'. The test materials were not washed off after treatment

Observation period:

There is no data on the observation period. At a minimum it appears that the animals were observed for the full 5 days during treatment.

Number of animals:

number of animals used is not indicated in the report

Details on study design:

Animals were prepared by closely clipping the skin over the anterior abdominal wall. After securing the animal in the supine position, a measured amount of the test material was pipetted onto the surface of the skin. The test material was allowed to evaporate in still air, and the animal was released to the cage after the skin was dry. The treatments were repeated daily until 5 had been made.

Irritation parameter:

overall irritation score

Remarks:

No score available from study

Time point:

other: 5 days

Reversibility:

not specified

Remarks on result:

other: limited data available from literature source but sufficient to determine irritability. Confirmed by additional testing

Irritant / corrosive response data:

No illness resulted from skin applications of the test material, and observations were limited to irritation. Two animals showed chemical dermititis, infiltration of the skin and subcutaneous tissues, superficial redness, and a considerable loss of hair. Burrowing lesions in the subcutaneous tissues were produced by the introduction of the test material into small wounds. There were no systemic effects noted and no significant bodyweight loss.

Highly irritating

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

Even though the reporting of this work is limited, it is clear from the report that AMP is irritant under the described experimental conditions.

Executive summary:

An undisclosed number of rabbits were shaved free of hair on the anterior abdominal wall. The rabbits were then secured in the supine position on an animal board and a measured amount of test material was pipetted onto the shaved area. No details of dose or approximate area of application are given. After test material administration the animals were left secured to the board in still air conditions until the test site was dry. No occlusive dressing was used and the test material was allowed to evaporate. Once the test site was dry each animal was returned to it's cage. This procedure was repeated daily for 5 days after which the animals were assessed for signs of illness and local effects at the test site. No illness resulted from the application of test compound to the skin and there were no signs of systemic toxicity or weight loss during the study. AMP caused a low grade chemical dermititis in two animals, infiltration of the skin and subcutaneous tissues, superficial redness, and a considerable loss of hair. Burrowing lesions in the subcutaneous tissues were produced by the introduction of the test material into small wounds. Based on the results of this experiment, AMP is considered to be irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation, other

Remarks:

Conducted study is in vivo and was conducted prior to the requirement for in vitro studies and before these asays were perfected for use

Type of information:

experimental study

Remarks:

the tested substance is AMP one of the components of the compound

Adequacy of study:

key study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study appears to have been conducted in accordance to a standard protocol (at the time) for assessing the eye irritation potential of compounds. Although there is limited information on the methods used the reporting is sufficient to come to a conclusion on the endpoint.

Principles of method if other than guideline:

Draize technique (Draize, J.H., Woodard, G. & Calvery, H.O. (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. and Exp. Therapeutics. 82, 377–390.)

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No details given

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml undiluted

Duration of treatment / exposure:

Animals were dosed with the test material, in one study the eyes were flushed 15-30 seconds after application, and in the other, they were not. No further methods information was given.

Observation period (in vivo):

scoring of results took place at 24 and 48 hours after exposure only. No further information on any subsequent observation period.

Number of animals or in vitro replicates:

6 animals in each study

Details on study design:

No additional Information

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48h

Score:

110

Max. score:

110

Reversibility:

not specified

Remarks on result:

other: un flushed eyes

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48h

Score:

69.3

Max. score:

110

Reversibility:

not specified

Remarks on result:

other: eye flushed after 15 seconds

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48h

Score:

89.3

Max. score:

110

Reversibility:

not specified

Remarks on result:

other: eye flushed after 30 seconds

Irritant / corrosive response data:

Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.

Other effects:

No details

Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material is considered to be a severe eye irritant, and there is little beneficial effect even when eyes are almost immediately flushed with water.

Executive summary:

In two studies of the eye irritation potential of AMP in rabbits, AMP was applied to the eyes of 6 rabbits (Strain and sex not recorded). In one study, the eyes were flushed with water 15 to 30 seconds post application, in the second study the eyes were not flushed with water. AMP caused severe damage to the eyes and flushing almost immediately with water appeard to have little beneficial effect. The Damage caused by AMP appears likely to be due to the high pH rather than any other type of chemical damage.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

the tested substance is the sodium salt of DDBSA one of the components 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

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 conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Both components are (severely) irritant to the skin. A study on the sodium salt of DDBSA indicated that this substance is irritating to the skin. As during dermal exposure limited dissociation can be expected, it is concluded that the sodium salt data are more relevant than the data on the acid. Therefore the substance is considered non-corrosive and needs to be classified as irritating to the skin.

Justification for classification or non-classification

Based on the study results on DDBSA (sodium salt) and AMP, the compound is considered irritating 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)