2-aminophenol

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: secondary source SCCS opinion on o-aminophenol 2010

Data source

Reference

Reference Type:

secondary source

Title:

Evaluation de la toxicite du produit orthoaminophenol administre chez le rat pendant 1 mois por voie orale

Author:

Boutemy C.

Year:

1989

Bibliographic source:

SCCS opinion on o-aminophenol 2010

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-aminophenol

EC Number:

202-431-1

EC Name:

2-aminophenol

Cas Number:

95-55-6

Molecular formula:

C6H7NO

IUPAC Name:

2-aminophenol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The age of the animals at the start of the study was approximately 6 weeks and the body weight range was 164 – 186 g for males and 134 –169 g for females. Food and water was supplied ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: hydrogel of 0.2 g polysorbate 80 and 0.2 g sodium carboxymethylcellulose

Duration of treatment / exposure:

30d

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0 (group I), 20 (group II), 80 (group III) and 320 (group IV) mg/kg bw/d
Basis:
actual ingested

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:

Clinical observation and mortality was checked daily.
Ophthalmoscopic examination was performed before and at the end of the study.
Body weights, food and water consumption were recorded twice weekly.
Haematology and blood biochemistry were determined at the end of the study.
Urinalysis was performed at the end of the study.
Necropsy, main organ weights, histopathological examination were undertaken at sacrifice time

Results and discussion

Results of examinations

Details on results:

Orange discoloration of the urines was observed throughout the study groups III and IV and orange discoloration of the fur in group IV females from day 7 on.
Signs of regenerative macrocytic anaemia in group IV males and females were seen.
Increase of GOT activity in group IV (males and females) and group III (males) was registered.
Increase of blood urea nitrogen was observed in group IV females as well as an increase of urinary proteins in group IV males and females.
Renal cells were seen in the urine in males of group II.
Increased relative liver and kidney weights in group IV males and females were recorded.
Kidneys were pale or mottled at macroscopic examination and showed renal tubular lesions at histopathological examination in males of group III and IV. Increased vacuolisation of the urothelium of the bladder in males and females in group II and III was present.

Effect levels

Dose descriptor:

NOAEL

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Target system / organ toxicity

Critical effects observed:

not specified