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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: published data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
LAS-C11.2
IUPAC Name:
LAS-C11.2
Test material form:
other: viscous liquid
Details on test material:
Alkylbenzene sulfonate, sodium salt (designated as P-500 N-Na). activity 47%. Average alkyl chain length = C11.2.
Yellow, viscous liquid.

Test animals

Species:
rat
Strain:
other: CFY (remote Sprague Dawley origin)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Rats were in a weight range of 210 to 239 g prior to dosing on day 1 and approximately six to eight weeks of age. All the rats were acclimated to the experimental environment for a period of 15 days prior to study initiation. Animals were housed in individual metal cages with wire mesh floors. Standard diet and water were provided ad libitum. Each animal was identified by cage number and ear punching.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test material was a yellow viscous liquid and was applied to an area clipped with electric clippers (approximately 10% of the area) on the backs of 10 rats (five male, five female) at a dose of 2000 mg/kg. The areas were covered with gauze held in place with an impermeable plastic dressing. At the end of 24 hours the dressings were carefully removed and the treated area of skin washed in warm water and blotted dry with absorbent paper.
Duration of exposure:
24 hr
Doses:
2000 mg/kg (undiluted)
No. of animals per sex per dose:
5 male and 5 female
Control animals:
not specified
Details on study design:
Animals were observed soon after dosing and then at frequent intervals for the remainder of day 1. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. The treated areas were examined daily for signs of dermal irritation and assessed according to the standard scoring system for erythema, eschar and oedema. All animals were observed for 14 days after dosing. On day 15 all animals were sacrificed and given a macroscopic post-mortem examination of internal organs.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: undiluted
Mortality:
No mortality was observed exposure to 2000 mg/kg of the undiluted test material.
Clinical signs:
There were no signs of systemic reaction. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressings. These reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7. Sloughing from the scabbed skin began at various times between day 7 and day 12 and was completed before test termination.
Body weight:
Low bodyweight gains or loss of bodyweight were recorded for one male and three female rats on day 8. Two of the same females and a third female rat also showed low bodyweight gains between days 8 and 15.
Gross pathology:
All terminal autopsy findings were normal.

Any other information on results incl. tables

There were no deaths or signs of a systemic reaction following a single dermal application at 2000 mg/kg bw. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressing on Day 2. All test sites were entirely covered by scab formation from Day 7. Sloughing from the scabbed skin began at various timesbetween Day 7 and Day 12 and was completed before termination. Lowbodyweight gains or loss of body weight were recorded for one male andthree females in Day 8. Two of the same females and a third female alsoshowed low bodyweight gain between Days 8 and 15.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose was found to be greater than 2000 mg/kg.
Executive summary:

The clipped skin on the backs of five male and five female rats were exposed to the test material under an occlusive dressing for 24 hours and observed for another 14 days. Results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg.

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