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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 18, 1986-March 31, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Alkylbenzene sulfonate, sodium salt (designated as P-500 N-Na). Activity 47%. Average alkyl chain length = C11.2. Clear yellow liquid stored at ambient temperature.

Test animals

Species:
rabbit
Strain:
other: New Zealand albino
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

Test system

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.

Results and discussion

In vivo

Results
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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 examined the potential for the test substance to cause dermal irritation. Three rabbits were exposed to 0.5 ml of the test substance dermally for 4 hrs. The test substance was covered with an occlusive dressing and removed by washing 4 hrs later. Animals were examined at 30 minutes after removal, and daily thereafter for 14 days. 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 animals 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.