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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test
Test material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% Carboxymethyl cellulose with 0.1% Tween 80 (test material in suspension)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
Male& Female: 0, 50, 200 and 1000 mg/kg bw/day
Basis:
no data
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Control animals:
not specified

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No deaths. Marked reduction in body weight gain of males at 1000 mg/kg.

Laboratory findings:
Increased activity of plasma ALT and AST at 1000 mg/kg (both sexes) and AST at 200 mg/kg (females). Plasma levels of urea and bilirubin were increased, and total globulins decreased, in males at 1000 mg/kg.
Effects in organs:
Increased relative liver weight, recent hepatic necrosis (extensive with haemorrhages in one high dose male, focal in one male at 200 mg/kg and two males at 50 mg/kg) and hepatocyte hypertrophy (most rats) were noted at 50 mg/kg and above; one male at 50 mg/kg had a liver nodule. Relative kidney weight was clearly increased at 1000 mg/kg and an apparent dose related trend was evident but no treatmentrelated lesions were seen.
Although lesions were seen at 50 mg/kg, no clear dose response was noted and, therefore, the substance should not be classified on the basis of this test.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
< 50 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: effects in organs (liver)
Dose descriptor:
NOEL
Effect level:
< 50 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: effects in organs (liver)

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Although lesions were seen at 50 mg/kg, no clear dose response was noted and, therefore, the substance should not be classified on the basis of this test.