Dodecane-12-lactam

Acute Toxicity: dermal

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

Test material information

Constituent 1

Reference substance name:

Dodecane-12-lactam

EC Number:

213-424-8

EC Name:

Dodecane-12-lactam

Cas Number:

947-04-6

Molecular formula:

C12H23NO

IUPAC Name:

1-azacyclotridecan-2-one

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 or test system 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:

other: Slight decrease in food comsumption (no quantitative data presented)

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.