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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, but according to guideline OECD 401
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
other: limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Araldite MY 720, TK 10884, batch no. 4356

Test animals

Species:
mouse
Strain:
other: Tif:MAG (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
4-5 week old mice, the mice were kept in groups of 2, in Macrolon cages type 2, with standarized soft wood bedding.
The animal room was air conditioned at 22 +/-3 °C, a relative humidity of 55 +/- 15%, a 12-hour light/dark cycle, and approximately 15 air changes per hour. Mouse standard food and water was supplied ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
-rior to dosing the animals were fasted over night.
Doses:
males and females were exposed to 5000 mg/kg body weight (single application)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Observation for mortality was on every day, mortality was checked daily, and body weight was determined on days 1, 7, 14, and at death
Statistics:
LD50 calculated including 95% confidence limits by the logit method (J. Berkson, J. Am. Stat. Ass. 39, 357 - 365 (1944)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
1/5 male mice died after 24 hours, no female mouse died at all (0/5)
Clinical signs:
sedation, dyspnoera, ruffeld fur, curved body position were the only symptoms observed, they disappeared on day 11 completely.
Body weight:
Body weight gain was normal in males and females.
Gross pathology:
no gross pathological findings were recorded.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 in mice is > 5000 mg/kg body weight with only one dead male mouse.
Executive summary:

The oral LD50 in mice is > 5000 mg/kg body weight with only one dead male mouse.