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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, no Guideline , but method similar to what has been later written down in to the guidelines.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The rabbits were shaved on the back and 48 hours later substance was applied to the shaved area and wrapped semi-occlusively for 24 hours, then skin reactions were scored over a period of 14 days.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Araldite MY 720, batch no. 1-73

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
All rabbits kept for seven days in quarantene before introducing to the test. Animals were housed individually, in suspended wire-mesh cages, food and water was supplied ad libitum.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: methal ethyl ketone
Details on dermal exposure:
rabbits were shaved on the back 48 hours before treatment, substance was dissolved in methyl ethyl ketone, and applied to the backs of the animals (30% of the animals body surface), the substance was then covered with a plastic sheet and fixed with a bandage to the animal. Animals were fixed a plastic collar to avoid licking on the sites. Substance remained 24 hours on the site, then the sites were washed and animals were observed daily for skin reactions and mortality.
Duration of exposure:
24 hours
Doses:
0, 1000, 3000 mg/kg bw
No. of animals per sex per dose:
2 male & 2 female rabbits per dose
Control animals:
yes, concurrent vehicle
Details on study design:
Initial and final body weights were measured, and at necropsy after 14 says a full observation of the entire organs was made, and organs were fixed in formalin for potential furhter investigations.
Statistics:
No statistical analysis was performed on the results

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
No mortality occurred during the 14 day observation period.
Clinical signs:
Ataxia and hyporeactivity were observed in all animals 1 hour post treatment, but disappeared within 24 hours. MY 720 was slightly irritant to the skin, while the solvebt caused only marginal skin reactions (irritation).
Body weight:
There were no body weight changes observed over the entire observation period.
Gross pathology:
No gross pathological changes were recorded during necropsy.
Other findings:
Histopathological examination of liver and kidney did not reveal any changes in the treated animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal treatment of rabbits with 1000 and 3000 mg/kg body weight for 24 hours did not cause any mortality or other sings of toxicity apart from slight irritation on the application sites.
The LD50 (dermal, in rabbits) is > 3000 mg/kg bw
Executive summary:

Dermal treatment of rabbits with 1000 and 3000 mg/kg body weight for 24 hours did not cause any mortality or other sings of toxicity apart from slight irritation on the application sites. The LD50 (dermal, in rabbits) is > 3000 mg/kg bw