Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Abstract information in OECD SIDS report of 2004; study described in OECD SIDS as valid without restrictions.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-2-naphthoic acid
EC Number:
202-180-8
EC Name:
3-hydroxy-2-naphthoic acid
Cas Number:
92-70-6
Molecular formula:
C11H8O3
IUPAC Name:
3-hydroxy-2-naphthoic acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
For lower doses, only females were treated.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
315; 500; 800; 1000; 1250 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
823 mg/kg bw
95% CL:
> 581 - < 1 070
Mortality:
Mortality occurred within 35-200 minutes after exposure.
1250 mg/kg: 5/5 (m), 4/5 (f)
1000 mg/kg: 3/5 (m), 3/5 (f)
800 mg/kg: 1/5 (m), 2/5 (f)
500 mg/kg: 2/5 (f)
315 mg/kg: 0/5 (f)
Clinical signs:
315, 500, 800 mg/kg bw: 10-30 minutes after application
reduced activity, prostrate and lateral positioning.
1000, 1250 mg/kg bw: reduced activity, prostrate and lateral positioning, accelerated breathing and closure of eyes. These signs were observed until the end of the day of application. Diarrhea was seen in all groups, beginning at 30 to 60 minutes after application.
All surviving animals were free of symptoms on day 1 after application.
Body weight:
There was no influence on body weight gain.
Gross pathology:
At necropsy, dark coloration of the liver was found in the high dose animals that had died, whereas light-coloured spots were seen in the livers of animals that died in the 500 and 800 mg/kg bw groups. Hyperemia and fluid were seen in the gastro-intestinal tracts. Animals that were killed at the end of the observation period were free of pathological changes.

Applicant's summary and conclusion