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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
other: limit test
Limit test:
yes

Test material

Constituent 1
Reference substance name:
4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane
EC Number:
500-062-3
EC Name:
4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane
Cas Number:
28390-91-2
IUPAC Name:
4-[(4-aminophenyl)methyl]aniline; 2-(chloromethyl)oxirane
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 or test system 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:
other: sedation, dyspnoera, ruffeld fur, curved body position were the only symptoms observed, they disappeared on day 11 completely.
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.