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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
Study period:
March-April 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, no guidelines; liver function was the focal parameter

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
6 rabbits were applied with a single dose of the test item on the shaved neck skin for 5 hours and observed for 7 days. Before the application and at day 1, 3 and 7, the activity of aspartate- and alanine aminotransfrase (AST and ALT) were measured in the peripheral blood. The survived animals were sacrificed at the end of the study and their liver was analyzed for hystologic abnormalities.
GLP compliance:
no
Test type:
other: liver functioning assessment after single dermal application
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: in single cages and with a plastic collar allowing to avoid the oral contact with the treated skin area

IN-LIFE DATES: From: 29 march 1976 To: 6 april 1976

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
REMOVAL OF TEST SUBSTANCE
- Washing: with a sponge and cold water
- Time after start of exposure: 5 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 g
Duration of exposure:
5 h
Doses:
5000 mg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: blood was collected and analysed for AST and ALT activity on days: 0, 1, 3 and 7
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, beahviour, micro and macroscopic examination of the liver

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 300 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No clinical sign reported
Body weight:
No data
Gross pathology:
No abnormality reported
Other findings:
After 24 hours the activities of of AST and ALT were slightly increased, but this effect was fully reversible whithin 7 days after the application.

Any other information on results incl. tables

Liver functioning parameters before and after the test item dermal application

 

AST

ALT

 

Initial value

t = 24 h

t = 3 d

t = 7 d

Initial value

t = 24 h

t = 3 d

t = 7 d

n

6

6

6

6

6

6

6

6

mean

4.7

14

5.3

2.3

31.3

57.5

41.7

31.7

S.D.

2.1

4.7

1.2

0.5

4.0

10.3

5.1

4.1

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Parachlorbenzotrifluorid exerted no adverse effect to rabbits after dermal application of 5000 mg for 5 hours. After 24 hours the activities of AST and ALT were slightly increased, but this effect was fully reversible whithin 7 days. No mortality, neither abnormal behaviour were observed during the 7 -days post-application period. No micro-, nor macroscopic findings were observed after hystological liver analysis.
Executive summary:

6 rabbits were applied with a single dose of the test item on the shaved neck skin for 5 hours and observed for 7 days afterwards. Before the application and at day 1, 3 and 7, the activities of aspartate- and alanine aminotransfrase (AST and ALT) were measured in the peripheral blood. After 24 hours the activities of AST and ALT were slightly increased, but this effect was fully reversible whithin 7 days after the application. No mortality, neither abnormal behaviour were observed during the 7 -days period. The survived animals were sacrificed at the end of the study and their liver was analyzed for hystologic abnormalities. No micro-, nor macroscopic findigs were reported.