Registration Dossier

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other: GLP compliant, guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents)
Version / remarks:
Guidelines for 28-Day Repeat Dose Toxicity Testing for Chemicals (Japan)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Aminobenzenesulfonic acid
- Purity : 98.6%

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% CMC-Na solution
Duration of treatment / exposure:
28 days
Doses / concentrations
Remarks:
Doses / Concentrations:
100, 300, 1000 mg/kg/day
Basis:
actual ingested
No. of animals per sex per dose:
7 (100, 300 mg/kg)
14 (0, 1000 mg/kg; 7 animals were used for 14 day recovery))
Control animals:
yes, concurrent vehicle
Details on study design:
Terminal kill: Day 29 or 43

Examinations

Observations and examinations performed and frequency:
CLINICAL SIGNS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
HAEMATOLOGY: Yes
BLOOD CHEMISTRY: Yes
URINALYSIS: Yes
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
ORGAN WEIGHT: YES
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Details on results:
Water consumption increased in males of the 1000 mg/kg group during the late phase of administration. Decreased urinary pH values were noted in both sexes receiving 1000 mg/kg. These changes disappeared by 14 days after withdrawal. No effects were observed in terms of clinical signs, body weighs, food consumption, hematology, blood chemistry, organ weights, and autopsy or histopathology findings.

Effect levels

Dose descriptor:
NOEL
Effect level:
300 mg/kg bw/day (actual dose received)
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion