Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Unavailable - study report dated 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
EC Number:
270-115-0
EC Name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
Cas Number:
68411-30-3
Molecular formula:
Not applicable for UVCB
IUPAC Name:
sodium 4-undecylbenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): alyklbenzene sulfonate, sodium salt (Na-LAS)
- Molecular formula (if other than submission substance): not available - not a single isomer
- Molecular weight (if other than submission substance): ca. 334.0
- Smiles notation (if other than submission substance): not available - not a single isomer
- InChl (if other than submission substance): not applicable

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 SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: Gauze held in place with an impermeable plastic dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated area of skin were washed in warm water and blotted dry with absorbent paper
- Time after start of exposure: At the end of 24 hours exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:
24 hours
Doses:
2000 mg/kg (undiluted)

No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: macroscopic post-mortem examination of internal organs.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study in rats conducted according to OECD 402 with sodium 4-undecylbenzenesulfonate, no mortality and no necropsy findings were observed at 2000 mg/kg bw. Signs of toxicity were seen during the observation period. Based on the results and in accordance with OECD guideline 402 the LD50 was determined to be higher than 2000 mg/kg bw. Therefore, classification of sodium 4-undecylbenzenesulfonate for acute dermal toxicity according to the CLP regulation 1272/2008 is not warranted.
Executive summary:

In an acute dermal toxicity study five Wistar rats per sex were dermally exposed to undiluted sodium 4-undecylbenzenesulfonate (purity not specified) for 24 hours to 10% of the surface area of rat backs at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.

All animals survived until the end of the study. 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. Low body weight 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 body weight gains between days 8 and 15. Finally, at necropsy, all terminal autopsy findings were normal.

Based on the results and in accordance with OECD guideline 402 the LD50 value was determined to be higher than 2000 mg/kg bw. Therefore, classification for acute dermal toxicity according to the CLP regulation 1272/2008 is not warranted.