ε-caprolactam

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

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

Remarks:

occlusive dressing instead of semi-occlusive

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: 84/449/EWG (Official Journal of EU, Nr. L251 from 19.09.1984, p 103)

Deviations:

yes

Remarks:

occlusive dressing instead of semi-occlusive

GLP compliance:

yes

Remarks:

(Bayer AG, Institute of Toxicology)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ε-caprolactam

EC Number:

203-313-2

EC Name:

ε-caprolactam

Cas Number:

105-60-2

Molecular formula:

C6H11NO

IUPAC Name:

azepan-2-one

Specific details on test material used for the study:

- Name of test material (as cited in study report): Epsilon-Caprolactam
- Physical state: solid
- Analytical purity: 99.9%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: male 9 weeks, female 14 weeks
- Mean weight at study initiation: male 230 g, female 211 g
- Diet (e.g. ad libitum): Altromin 1324 pellets
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 50±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- % coverage: 10%
- Type of wrap if used: The treated area was covered and fixed with aluminum foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h


TEST MATERIAL
- 3ml/kg bw test substance was applied

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight of individual animals was measured before treatment and after 7 and 14 days of treatment, daily clinical inspection
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortalities were observed

Clinical signs:

other: no clinical signs were observed

Gross pathology:

no abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value has been found to be greater than 2000 mg/kg bw in rats.

Executive summary:

This study is a limit dose test with rats performed similar to guideline with GLP. 24 h of dermal exposure to 2000 mg/kg bw under occlusive conditions resulted in no mortalities or signs of toxicity.