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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Although application area was rather small, this was not considered to have significantly influenced the outcome of the study; OECD Guideline 402 and GLP-compliant study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dichloromethane (Production: TA, June 1985), a volatile colourless liquid. The test material was supplied by Solvay and Cie, Bruxelles, Belgium.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
SPF-derived males (180-200 g) and femals (160-180 g) at arrival.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
applicaton surface was 15 cm2
Duration of exposure:
24 hours, 14 days observation period
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
yes
Details on study design:
For ethical reasons the control group was used for a number of studies which were carried out in parallel. The data of this group are filed under study no. DT 88/17.

Investigated parameters: clinical signs, body weights and body weight gains, autopsy and organ weights.
Statistics:
The results were evalulated with an analysis of variance followd by a Student t-test (two-sided).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Mortality was not observed.
Clinical signs:
Vocalization was observed in the first half an hour of treatment in all males and 2 females. All males of the treated group and one female of the control group were a little bit quiet. At 1 .5 hours after application period signs had disappeared.
Body weight:
The animals showed normal weight gain
Gross pathology:
4 males and 4 females showed swollen or slightly swollen livers (compared with 1 male and 1 female in the controls).
Absolute and relative liver weights of the males were statistically significantly decreased.

Other findings:
No effects were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 2000 mg/ktg bw.