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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
see "Details on dermal exposure" and "Details on study design"
GLP compliance:
no
Test type:
other: single dose was used
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Laurolactam, pure white, caked material with intensive smell, ground before application. No data on impurities or origin.
Specific details on test material used for the study:
Lauryl lactam supplied by Elf Atochem, purity not stated

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation:
- 5 male and 5 female rats, supplied from IFFA-CREDO
325-374 g, mean 356 g (males)
220-270 g, mean 236 g (females)
- Controls: untreated. No details reported.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
- test substance preparation: the test substance was ground to fine powder and suspended in 1% aqueous carboxy methyl cellulose
- to the shaved back of the animals
- Occlusion: yes, for 24 hours
- Vehicle: 1 % carboxy methylcellulose (CMC) aqueous suspension
- Concentration in vehicle: 40 %
- Total volume applied: 5 ml/kg bw
- Removal of test substance: yes, washed off with lukewarm water 24 hours after administration.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
EXAMINATIONS:
- clinical observations after end of exposure,
repeated during next hours, and
repeated daily for 14 days
- autopsy after 14 days observation period.
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortalities
Clinical signs:
Slight decrease in food comsumption (no quantitative data presented)
Body weight:
Stagnation of body weight development (356, 352, 354 g mean body weight for males at d1, d7 and d14, respectively; 237, 236, 240 g mean body weight for females at d1, d7 and d14, respectively).
Gross pathology:
No findings
Other findings:
IRRITATION: no skin effects at all were noted.

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
In a determination of the acute dermal toxicity on male and female rats it was found that the LD50 of the test item Dodecane-12-lactam (lauryl lactame) is above 2000 mg/kg of body weight. Under the conditions of this study the acute toxicity of Dodecane-12-lactam (lauryl lactame) afer dermal application in rats is very low.
Executive summary:

The test item Dodecane-12 -lactam (lauryl lactame) was applicated at the skin of the male and female rats in a dose of 2000 mg/kg body weight. No mortalities were observed at this dose. Hence the LD50 of the acute dermal toxicity on male and female rats is above 2000 mg/kg of body weight for the test item Dodecane-12-lactam (lauryl lactame) in rats.

Under the conditions of this study the acute toxicity of Dodecane-12-lactam (lauryl lactame) afer dermal application in rats is very low.