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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:
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:
cyclooctene of Hüls AG; Purity: 92.7 %

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 244 g, females mean 189 g
- Fasting period before study: 16 hours
- Water: ad libitum
- Diet: ad libitum
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 1 °C
- Humidity (%): 60 % +/- 5%
- Air changes (per hr): 15 times/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark rythm

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
ADMINISTRATION: 
- Doses per time period: three applications within four hours
- Post dose observation period: 14 days
- Controls: no
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
EXAMINATIONS:
- Clinical signs and mortality: within 6 hours after treatment,  thereafter daily
- Body weights: before, and 1, 7, 14 days post dosing
- Necropsy: 5 males and 5 females (macroscopic), no further details

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
MORTALITY: No deaths occurred
Clinical signs:
CLINICAL SIGNS: 
The signs of toxicity observed immediately after  application were opisthotonos and uttering of sounds, and later on slight  sedation and bleeding of eyes and noses as well as erythema of the skin.  The findings had disappeared after 48 hours, with the exception of eschar  formation. 
Body weight:
Body weight gain was not affected
Gross pathology:
NECROPSY FINDINGS: 
Dissection at the end of the observation period  revealed a reddish discoloration of the small intestinal mucosa in 4/10  animals. None of the other 
animals showed any abnormal  anatomicopathological organ findings. 

Applicant's summary and conclusion

Conclusions:
In an acute dermal toxicity study according to OECD TG 402 a limit dose of undiluted cyclooctene was applied to the skin of a group of young rats (5 per sex) at a limit dose of 10000 mg/kg bw. Animals were observed for 14 days. There were no mortalities.(LD50: > 10000mg/kg bw).
Executive summary:

In an acute dermal toxicity study according to OECD TG 402 a limit dose of undiluted cyclooctene was applied to the skin of a group of young rats (5 per sex) at a limit dose of 10000 mg/kg bw. Animals were observed for 14 days. There were no mortalities. Signs of toxicity were observed up to 48h post treatment. Body weight gain was not affected. At necropsy reddish discoloration of the small intestine was noted in 4 of ten animals and no other observations were noted. Cyclooctene was practically non-toxic in this study.