Registration Dossier

Administrative data

Description of key information

The potential for dermal irritation was examined in a study on the test substance. The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of the LAB Sulfonic Acid 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 primary dermal irritation index was 5.25 (mean of 1, 24, 48 and 72 hours). The test substance is considered a Category 1C irritant/corrosive according to CLP guidelines based on persistent irritation (H314: Causes severe skin burns and eye damage).

The potential for irritation to eyes was examined in a study on the test substance. The eyes of six rabbits were treated with LAB Sulfonic Acid and observed for six days. 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. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6. According to these results, the test substance is a category 1 eye irritant according to CLP because it caused damage that was not reversible within the 6 days of the study (H318: Causes serious eye damage).

LAB Sulfonic Acid is corrosive to the skin and eyes at a 100% undiluted, unrinsed dose and is classified under the CLP as category 1 C for skin, and category 1 for eye.

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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Laboratory study in experienced testing laboratory.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
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:
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
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Laboratory study in experienced laboratory.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
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.

 

Results of Eye Irritation Study in Rabbits

Observation

Endpoint

Male

11655

Male

11715

Male

11771

Female

11798

Female

11804

Female

11838

1 hr

Cornea ¿ degree

1

1

2

2

2

1

1 hr

Cornea ¿ range

4

4

4

4

4

4

1 hr

Iris

1X

1X

1X

1X

1X

1X

1 hr

Conjunctiva ¿ redness

3N

3N

3N

2N

3N

3N

1 hr

Conjunctiva ¿ edema

1

1

1

1

2

2

1 hr

Conjunctiva - exsudation

3

3

3

3

3

3

24 hrs

Cornea -degree

1

1

2

2

3C

1

24 hrs

Cornea ¿ range

4

4

4

4

2

4

24 hrs

Iris

1*

1*

1*

1*

1*-

1*

24 hrs

Conjunctiva ¿ redness

3N

3N

3N

3N

3N S

3N

24 hrs

Conjunctiva ¿ edema

2

2

2

2

2

3

24 hrs

Conjunctiva - exsudation

2

2

2

2

2

2

48 hrs

Cornea ¿ degree

1

1

2

2

3C

1

48 hrs

Cornea - range

4

4

4

4

2

4

48 hrs

Iris

1*

1*

1*

1*

1*-

1*

48 hrs

Conjunctiva ¿ redness

3N S

3N

3N S

3N S

3N S

3N S

48 hrs

Conjunctiva ¿ edema

2

1

1

1

2

3

48 hrs

Conjunctiva - exsudation

2

2

2

2

2

2

72 hrs

Cornea ¿ degree

1

1

1

2

4C

1

72 hrs

Cornea - range

4

2

4

4

2

4

72 hrs

Iris

1X

1X

1*

1*

1*-

1*

72 hrs

Conjunctiva - redness

3N S

3N S

3N S

3N S

3N S

3N S

72 hrs

Conjunctiva ¿ edema

2

2

2

2

2

2

72 hrs

Conjunctiva - exsudation

2

2

2

2

2

2

6 days

Cornea ¿ degree

2

2

2

2

4C

2

6 days

Cornea -range

3

3

2

3

2

4

6 days

Iris

1X

1X

1*

1*

1*-

1*

6 days

Conjunctiva - redness

3N S L

3N L

3N L H

3N S L

3N S L

3N S L

6 days

Conjunctiva ¿ edema

2

2

2

2

2

2

6 days

Conjunctiva - exsudation

2

1

2

2

2

2

C ¿ Cornea cloudy

X ¿ Parts of the iris turned red

* - Iris turned red

- - Retarded iris reaction

N ¿ Necrosis and corrosion of the conjunctiva

S ¿ Secretion formation

L ¿ Lids became encrusted

H ¿ Holding head inclined

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Result: moderately irritating
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 conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

LAB Sulfonic Acid was tested and found to be irritating to both the skin and eyes of test animals. In skin, 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. In eyes, LAB Sulfonic Acid was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6. According to these results, the test substance is classified as CLP category 1C for skin irritation (H314: Causes severe skin burns and eye damage) and CLP category 1 for eye irritation (H318: Causes serious eye damage).


Justification for selection of skin irritation / corrosion endpoint:
Key studies are reliable without restriction, report in vivo experimental results from 2 studies.

Justification for selection of eye irritation endpoint:
Key study is reliable without restriction, reports in vivo experimental results.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Undiluted LAB Sulfonic Acid was tested and found to be corrosive to both the skin and eyes of test animals.