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: Small number of animals investigated, but meets generally accepted scientific standards; sufficiently documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The undiluted compound was applied in increasing doses at increments of o.2 fractional log intervals to the closely clipprd, intact skin of New Zealand White male and female rabbits. The treated areas were covered with plastic strips and the animals held in wooden stocks for periods up to 24 hours, after which time they were assigned to individual cages. Observations were made for toxic signs during a 14-day period after dosing and the viscera of the test animals were examined macroscopically.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Mondur PF; no further data given

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1.8 - 2.3 kg
- Fasting period before study: no data
- Housing: individual
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no data
- % coverage: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours


Duration of exposure:
24 hours
Doses:
5010, 7940 mg/kg
No. of animals per sex per dose:
1 male (5010 mg/kg); 1 male and 1 female (7940 mg/kg)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes (viscera only)
- Other examinations performed: clinical signs, body weight
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Mortality:
All three animals survived the treatment with 5010 and 7940 mg/kg bw.
Clinical signs:
Toxic signs included reduced appetite and activity for two to three days.
Body weight:
All three animals showed slightly reduced body weights (- 0.1 kg) five days after the treatment.
Gross pathology:
The viscera appeared normal by macroscopic examination.
Other findings:
no data

Applicant's summary and conclusion

Executive summary:

The acute dermal toxicity of Mondur PF was low with an LD50 value > 7940 mg/kg bw for male and female rabbits. Single administration of 7940 mg/kg bw over 24 hours was tolerated without mortality, but transient signs of reduced activity were observed.