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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restricition (no information on determination of the body weights)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Carcinogenesis bioassay of melamine (CAS No. 108-78-1) in F344/N rats and B6C3F1 mice
Author:
NTP
Year:
1983
Bibliographic source:
NIH publication No. 83-2501, TR 245
Reference Type:
publication
Title:
Urolithiasis and bladder carcinogenicity of melamine in rodents
Author:
Melnick R.L. et al
Year:
1984
Bibliographic source:
Toxicol. Appl. Pharmacol., 72, 292-303

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no information on the determination of body weights
GLP compliance:
no
Remarks:
NTP-Standard (stated in the OECD SIDS 2002)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: ca. 97%

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Frederick Cancer Research Center
- Age at study initiation: 10 weeks
- Housing: 2-3 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26 °C
- Humidity (%): 30 - 70%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2150, 3160, 4640, 6810, and 10000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: Observed for mortality every 30 min for the first 8 hours and then daily for 14 days
- All animals were necropsied

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3 161 mg/kg bw
95% CL:
1 344 - 4 722
Sex:
female
Dose descriptor:
LD50
Effect level:
3 828 mg/kg bw
95% CL:
2 787 - 5 255
Mortality:
Deaths of animals administered a single dose of melamine were dose related (cf. table 1).
Gross pathology:
White crystals (not further identified) were found in the stomach of some animals (cf. table 1)

Any other information on results incl. tables

Table 1: Test results

Dose level (mg/kg bw)

Males

Females

Deaths

Crytals in stomach

Deaths

Crystals in stomach

2150

2/5

1/5

0/5

0/5

3160

1/5

1/5

2/5

2/5

4640

4/5

No data

3/5

No data

6810

5/5

4/5

5/5

5/5

10000

5/5

3/5

5/5

4/5

Applicant's summary and conclusion