Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study report with limitations but overall acceptable for risk assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
other: dermal toxicity study, the sample was applied to the clipped trunk of six male albino rabbits at a single dose level of 200 mg/kg of body weight over a 24 hour period. After exposure, the wrappings were removed and the skin was washed with water. The animals were observed for 48 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No additional information.

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
Six male albino rabbits were used in this study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
The sample as received was applied at a single dose level of 200 mg/kg of body weight. Average dose was 0.67 mL.
Duration of treatment / exposure:
24-hour exposure period.
Observation period:
Animals were observed for 48 hours.
Number of animals:
5 male albino rabbits.
Details on study design:
The rabbits were restrained in stocks and their trunks wrapped loosely with aluminium foil and rubber dam for the 24-hour exposure period. After the exposure, the wrappings were removed and the skin washed with water. The animals were observed for 48 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema with oedema
Basis:
other: no data
Time point:
other: 24 h
Reversibility:
no data
Remarks on result:
other: mild to moderate
Irritation parameter:
other: erythema
Basis:
other:
Time point:
other: 48 h
Reversibility:
no data
Remarks on result:
other: generally mild to moderate
Irritant / corrosive response data:
Clinical signs after 1 day - mild to moderate skin erythema with oedema.
Clinical signs after 2 days - generally mild to moderate skin erythema.
Other effects:
0/6 mortality ratio.

Any other information on results incl. tables

Average initial body weight was 3231g, average final body weight was 3078g.

Applicant's summary and conclusion

Conclusions:
2-Chloro-1, 3-butadiene does not classify as a Class B poison via the skin absorption route when tested according to the ICC regulations as no deaths occurred when applied at a level of 200 mg/kg of body weight. However, under these semi-occluded conditions, it would be considered a moderate primary irritant and care should be taken to avoid skin contact.
Executive summary:

2-Chloro-1, 3-butadiene does not classify as a Class B poison via the skin absorption route when tested according to the ICC regulations as no deaths occurred when applied at a level of 200 mg/kg of body weight. However, under these semi-occluded conditions, it would be considered a moderate primary irritant and care should be taken to avoid skin contact.