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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and is described in sufficient detail

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monomethylamine ( 40% aqueous solution)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: animals were on comparable body weights (+/- 20 g)
- Fasting period before study: 16 hours
- Housing: 5 animals per cage
- Diet (e.g. ad libitum): SSNIFFR, Versuchstierdiaeten
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
825, 464, 215 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, histopathology and suvival wre recorded

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
698 mg/kg bw
Mortality:
825 mg/kg: 7 animals died
464 mg/kg: 1 animal died within 2 days
Clinical signs:
825 mg/kg: dyspnea, apathy, ataxia, ecxidosis (males), cachexia (males)
464 mg/kg: apathy, gasping, bad general condition (males)
Gross pathology:
Animals found dead:
825 mg/kg: strong irritation and bloody content in stomach and intestine
464 mg/kg: no pathology possible due to starting putrefaction
Sacrifced animals:
Nothing abnormal detected.

Any other information on results incl. tables

Mortality

 Dose (mg/kg)  No. of animls  died within1h  1 day  2 days  7 days  14 days
 825  5 male  0  1  1  1  2
   5 female  0  5  5  5  5
 464  5 male  0  0  1  1  1
   5 female  0  0  0  0  0
 215  5 male  0  0  0  0  0
   5 female  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information: According to the criteria in CLP Annex I, 3.1.2 to 3.1.3.4.
Conclusions:
Methylamine caused corrosive injury to the stomach if ingested
Executive summary:

An oral acute toxicity study performed by BASF AG in 1982, Methylamine as aqueous solution of 40% was administered orally to rats (test group consisting of 5 rats, strain: Wistar/sex) at doses of 215, 464 and 825 mg/kg bw. Observations for mortality and for clinical symptoms of toxicity were performed. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy. As effect level the LD50 was considered to be around 698 mg/kg bw. Bad general condition, dyspnea, gasping, apathy, ataxia, exsiccosis and cachexia were observed in treated animals. The effects were more pronounced in males. The severity of effects carried a clear dose-dependent character. Strong irritation and bloody content in stomach and intestine were recorded in animals that died after exposures. At the highest dose administered (825 mg/kg) 7 animals died. At 464 mg/kg one animal died in the first 48 hours after drug administration. There were no abnormalities in sacrificed animals, beside the strong irritation of the stomach and the intestines in rats treated with 825 mg/kg. Additionally a bloody content was found in the stomach and the intestine of the rats treated with the highest dose administered. Based on the findings methylamine is classified a toxicity category IV (GLP Annex I).