Registration Dossier

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:
other: Secondary literature; no further details available than those documented below (e.g. no details about test substance, no data about number of animals or post exposure observation period).

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Information profiles on potential occupational Hazards: Glycols
Author:
NIOSH
Year:
1982
Bibliographic source:
PB 89-215776
Reference Type:
other company data
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Limit test comparable to OECD Guideline 402 but occlusive dressing (worst case scenario).
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
2,2-Dimethyl-1,3-propanediol

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: acetone-cornoil mixture
Details on dermal exposure:
20% solution in vehicle
Duration of exposure:
24 h
Doses:
4000 mg/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
depilated skin of guinea pigs; impervious coverage; no further details
Statistics:
no data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Remarks on result:
other: Limit test
Mortality:
no mortality
Clinical signs:
Only slightly to moderately irritating; no evidence for systemic toxicicity; skin absorption is not excluded comparing with effective dose levels in acute oral toxicity (see Section 7.2.1).
Body weight:
no data
Gross pathology:
no data
Other findings:
no

Applicant's summary and conclusion

Conclusions:
No mortality in guinea pigs after occlusive dermal exposure for 24 h to 4000 mg/kg bw.
Executive summary:

The data are from secondary literature; no further details available than those documented above (e.g. no details about test substance, no data about number of animals or post exposure observation period).

Guinea pigs were dermally exposed to 4000 mg/kg bw for 24 h. An occlusive coverage was used. No mortality was found; no systemic toxicity was detected. Only slightly to moderately irritating effects were reported. But skin absorption is not excluded from these results comparing with effective dose levels in acute oral toxicity.

Conclusion: No mortality in guinea pigs after occlusive dermal exposure for 24 h to 4000 mg/kg bw.