Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-05-25 to 1983-06-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Cyclooctadiene of Hüls AG; Purity 99.5 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: males mean 251 g, females mean 191 g
- Controls: no
- Diet: ad libitum, R10 special diet for rats, SSniff R
- Water: ad libitum, tap water
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 1 °C
- Humidity: 60 +/- 5 %
- Photoperiod: 12 hours artificial light, 12 hours dark
- Air changes: 15 per hour

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
ADMINISTRATION: 
- Doses per time period: three doses within 4 hours
- Post dose observation period: 14 days
Duration of exposure:
not rinsed
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days post dosing
- Clinical signs and mortality: within 6 hours after dosing, thereafter  daily
- Necropsy: 2 per sex and dose group (macroscopic), no further details
Statistics:
not applicable

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
MORTALITY: No deaths
Clinical signs:
CLINICAL SIGNS: Straub reaction immediately after application, sedation  after one hour, and later ataxia and slight erythema of the dorsal skin  
(up to 48 hours after treatment)
Body weight:
No effect on body weight gain
Gross pathology:
NECROPSY FINDINGS: No indications of substance related effects were  observed after the end of the observation period of 14 days.
Other findings:
no other findings

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
Under the present test conditions, the dermal LD50 value was determined to be greater then 10000 mg/kg bw in rats for the test item.
Executive summary:

In a determination of the acute dermal toxicity on male and female rats it was found that the LD50 of the test item is greater than 10000 mg/kg. The treated animals showed signs of toxicity for up to 48 hours. There was no influence on the increase in body weight. Dissection at the end of the experiment revealed no evidence of macroscopically detectable organ changes.