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Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Referenceopen allclose all

Reference Type:
other: study report
Title:
"Twenty-eight-day Repeat Dose Oral Toxicity Test of 2-Amino-5- methylbenzenesulfonic acid in Rats".
Author:
Ministry of Health & Welfare, Japan
Year:
1996
Bibliographic source:
Toxicity Testing Reports of Environmental Chemicals, vol.4 p99-106,
Reference Type:
other: study report
Title:
Assessment Report for 4-AMINOTOLUENE-3-SULFONIC ACID CAS N°: 88-44-8
Author:
OECD SIDS
Year:
2003
Bibliographic source:
SIDS Initial Assessment Report For SIAM 16 Paris, 27-30 May 2003

Materials and methods

Principles of method if other than guideline:
28 days subacute repeated dose toxicity study of 4-aminotoluene-3-sulphonic acid in rat was conducted to evaluate adverse effects on clinical signs and mortality,body weight,food consumption by oral route.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
4-aminotoluene-3-sulphonic acid
EC Number:
201-831-3
EC Name:
4-aminotoluene-3-sulphonic acid
Cas Number:
88-44-8
IUPAC Name:
2-amino-5-methylbenzenesulfonic acid
Details on test material:
- Name of test material (as cited in study report): 4-aminotoluene-3-sulphonic acid
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation:5 weeks
- Weight at study initiation:168-183 g for males, 138-162 g for females
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil, 0.5mL/100g body weight
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
once a day
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 300 and 1000 mg/kg/day
Basis:

No. of animals per sex per dose:
6 per sex per dose
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: every day
BODY WEIGHT: Yes
- Time schedule for examinations: twice a week, total 9 times during the 28 days
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Time schedule for examinations: Once a week (24hr consumption)
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
HAEMATOLOGY: Yes
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- Parameters checked: blood cell count, total cholesterol
URINALYSIS: Yes
- Parameters checked: urine pH
Sacrifice and pathology:
GROSS PATHOLOGY: No data
HISTOPATHOLOGY: No data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No change in mortality and behavior
Mortality:
no mortality observed
Description (incidence):
No change in mortality and behavior
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No toxic effect was observed
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No toxic effect was observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Description (incidence and severity):
No toxicological effects was observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
no effects observed
Description (incidence and severity):
No toxicological effects was observed
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
No toxicological effects was observed
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
300 other: mg/kg/day bw
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Effects: No change in mortality and behavior were observed in any groups.body weight and food consumption: No toxic effect was observed in any groups.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The 28 days sub-acute repeated dose study on male and female rat indicated that no effects observed on clinical sign, mortality, body weight, food consumption, urinalysis, organ weight, and haematology.
Thus, on the basis of study results the NOAEL (No observed adverse effect level) was observed to be 300 mg/kg/day bw.
Executive summary:

In order to determined the repeated oral toxicity of 4-aminotoluene-3-sulphonic acid, after 14 days preliminary study a 28 days sub acute repeated dose toxicity study inSprague-Dawleyrats (male and female) was conducted at dose levels of 0(vehicle), 100, 300 and 1000 mg/kg/day by oral gavage route .

From experimental study no clinical sign, mortality, body weight, food consumption, urinalysis, organ weight, and haematology at mid dose group.

Thus, on the basis of above results the NOAEL (No observed adverse effect level) for 4-aminotoluene-3-sulphonic acid was considered to be 300 mg/kg/day bw.