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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Japanese Guidelines on Industrial Chemicals (1986), equivalent to 92/69/EEC used.
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

1
Chemical structure
Reference substance name:
2,2-bis(hydroxymethyl)butanoic acid
EC Number:
424-090-1
EC Name:
2,2-bis(hydroxymethyl)butanoic acid
Cas Number:
10097-02-6
Molecular formula:
C6H12O4
IUPAC Name:
2,2-bis(hydroxymethyl)butanoic acid
Details on test material:
supplier: study sponsor
Batch No: 4K02

Test animals

Species:
rat
Strain:
other: SD (Crj:CD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: purified water
Details on oral exposure:
The four week treatment period was followed by a 2-week recovery period (groups 1,4 and 5 only, 6 males and 5 females per group).
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
8 mg/kg bw/day (nominal)
Dose / conc.:
40 mg/kg bw/day (nominal)
Dose / conc.:
200 mg/kg bw/day (nominal)
Dose / conc.:
1 000 spores/kg bw/day (nominal)
No. of animals per sex per dose:
Male: 6 animals at 0 mg/kg bw/day
Male: 6 animals at 8 mg/kg bw/day
Male: 6 animals at 40 mg/kg bw/day
Male: 6 animals at 200 mg/kg bw/day
Male: 6 animals at 1000 mg/kg bw/day
Female: 6 animals at 0 mg/kg bw/day
Female: 6 animals at 8 mg/kg bw/day
Female: 6 animals at 40 mg/kg bw/day
Female: 6 animals at 200 mg/kg bw/day
Female: 6 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
There were no deaths.
Soiled perineal region was observed in male rats treated at 1000 mg/kg/day. Four males showed soiling from 19 days after commencement of treatment until the end of the treatment period and one showed only transient soiling. No such effects were seen in any animal during the recovery period.
No clinical signs were noted in any other group.

Laboratory findings:
No treatment-related changes in urinalysis, blood chemistry or haematology parameters were found.

Effects in organs:
No treatment-related effects were observed.

Effect levels

open allclose all
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Remarks on result:
other: original NCD unit is mg/kg/day.
Key result
Dose descriptor:
NOEL
Effect level:
200 mg/kg bw/day (nominal)
Sex:
male/female
Remarks on result:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No specific toxic effect was observed
Executive summary:

To evaluate the toxicity of the test substance a subacute study in rats by oral route was performed. The study was conducted in accordance with B.7 92/69/EEC of July 31, 1992. The test substance was administered orally via gavage to groups of 6 male and 6 female Crj:CD (SD) IGS rats using target doses of 0, 8, 40, 200 and 1000 mg/kg bw/d for 4 weeks. Based oh the results of the study, 1000 mg/kg bw/d was established as the no-observed-adverse-effect-level (NOAEL) and 200 mg/kg bw/d the no-observed-effect-level (NOEL) for male and female rats.