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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: according guideline 84/449/EWG

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Guideline:
other: Directive 84/449/EWG
Principles of method if other than guideline:
Method: other: Directive 84/449/EWG
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Thymol 99.5/99.6 % (peak area)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
male and female Wistar rats, SPF, average weight 210 g (males) and 197 g (females), animals were housed in macrolon cages type II

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Cremophor
Details on dermal exposure:
substance was individually prepared on an aluminium foil, mixed with cremophor and fixed on the animals by means of plaster
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
animals were inspected daily for clinical signs
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing before application, after 1 week and and at the end of the obserbation period of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
not necessary (limit test)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no symptoms of poisoning
Body weight:
males: animal 1: day 0 weight 205 g, day 7 weight 235 g, day 14 weight 250 g;
animal 2: day 0 weight 210 g, day 7 weight 240 g, day 14 weight 249 g;
animal 3: day 0 weight 215 g, day 7 weight 241 g, day 14 weight 251 g;
animal 4: day 0 weight 213 g, day 7 weight 239 g, day 14 weight 248 g;
animal 5: day 0 weight 209 g, day 7 weight 218 g, day 14 weight 245 g;
females: animal 1: day 0 weight 190 g, day 7 weight 200 g, day 14 weight 208 g;
animal 2: day 0 weight 198 g, day 7 weight 205 g, day 14 weight 215 g;
animal 3: day 0 weight 199 g, day 7 weight 209 g, day 14 weight 217 g;
animal 4: day 0 weight 200 g, day 7 weight 208 g, day 14 weight 210 g;
animal 5: day 0 weight 198 g, day 7 weight 205 g, day 14 weight 215 g;
Gross pathology:
no findings
Other findings:
a brownnish discoloration on skin areas was observed at the application side on some animals

Any other information on results incl. tables

mortality: 0/10; no pathological changes (post observation  
time 14 days)

After a single dose of 2000 mg/kg no signs of intoxication
were observed. The application area showed a brownish discoloration
concerning 3 male and 2 female rats. The discoloration exists up to 4 days

Applicant's summary and conclusion

Executive summary:

method: 2000 mg/kg bw of the test substance was applied occlusive for 24 h on 5 male and 5 female rats.

Post observation time was 14 days

results: LD50 > 2000 mg/kg bw; no pathological changes and no signs of intoxication were observed

reference: Bomhard (Bayer AG), 1986