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: According or similar to a guideline study, with acceptable restrictions. No data is provided on substance purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: not stated
Principles of method if other than guideline:
Test material was applied to the shaved and abraded skin of rabbits and covered with an occlusive dressing for 24 hours. The material was removed, skin gently rinsed and the animals were observed for 14 days for morbidity and mortality.
GLP compliance:
not specified
Remarks:
precedes establishment of guideline
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
other: Albino
Sex:
male/female
Details on test animals and environmental conditions:
Four groups of four albino rabbits (2 male & 2 female) weighing between 2.0 and 3.0 kg each were employed in this study. All animals had their backs clipped free of hair 24 hours prior to testing. All of the animals had their backs abraded prior to dosing.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
All rabbits were weighed and the correct amount of experiemental material was applied to the back of each animal.
Doses:
0.5 gm/kg, 1.0 gm/kg, 2.0 gm/kg, 4.0 gm/kg
No. of animals per sex per dose:
4 groups of 4 albino rabbits (2 male and 2 female)
Details on study design:
14 day observation period

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 other: gm/kg
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
2 - 4 other: gm/kg
Based on:
test mat.
Mortality:
One male animal died at 2.0 gm/kg. Deaths occurred between 18-36 hours for males and females (2 each) at 4.0 gm/kg
Clinical signs:
No untoward symptoms were noted at 0.5 gm/kg. At 1.0 gm/kg, the animals were depressed after 24 hours, but appeared normal by 48 hours. At 2.0 gm/kg, the animals were severely depressed, ataxic, cold and demonstrating involuntary muscle tremors by 24 hours. Surviving animals at 2.0 gm/kg appeared normal after 7 days. At 4.0 gm/kg, the animals were severely depressed after 8-12 hours and comatose within 18 hours.
Body weight:
At 2.0 gm/kg, weight gain was below average.
Gross pathology:
Revealed nothing remarkable

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD50 of male/female is > 2000 mg/kg bw. Criteria used for interpretation of results: EU
Conclusions:
3-Cyanopyridine as tested in male rabbits has an acute dermal LD50 of approximately 2.0 gm/kg and an acute dermal LD50 of approximately 2.0 gm/kg - 4.0 gm/kg for female rabbits.