3-hydroxy-2-naphthoic acid

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

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 1

Reference Type:

secondary source

Title:

Unnamed

Year:

2010

Reference 2

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report For SIAM 19 - 3-Hydroxy-2-naphthoic acid

Author:

Anonymous

Year:

2004

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

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

Details on test material:

- Name of test material (as cited in study report): 3-hydroxy-2-naphthoic acid
- Analytical purity: 99.2%
- Impurities (identity and concentrations): no data

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rat/Crj :CD (SD) used
- Age at study initiation: (P) x 5 wks for males and 10 wks for females;
No additional information

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:

DIET PREPARATION
The test was administered in 0.5 % Sodim carbaxymethyi-cellulae solution (no additional information)

Details on mating procedure:

- M/F ratio per cage: 1/1; no additional details

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

test substance was given to the d e s for 10 weeks before mating and 4 weeks thereafter, and to the females for 2 weeks before mating and throughout gestation and lactation periods, in total for 8 weeks

Frequency of treatment:

daily

Details on study schedule:

- Age at mating of the mated animals in the study: 15 weeks for males and 20 weeks for females

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 12.5, 50 and 200 mg/kg bw per day
Basis:
actual ingested

No. of animals per sex per dose:

25

Control animals:

yes, concurrent vehicle

Details on study design:

no additional detail available

Positive control:

none

Examinations

Parental animals: Observations and examinations:

no details information available in the abstract

Oestrous cyclicity (parental animals):

no details information available in the abstract

Sperm parameters (parental animals):

no details information available in the abstract

Litter observations:

no details information available in the abstract

Postmortem examinations (parental animals):

no details information available in the abstract

Postmortem examinations (offspring):

no details information available in the abstract

Statistics:

no details information available in the abstract

Reproductive indices:

no details information available in the abstract

Offspring viability indices:

no details information available in the abstract

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

The treatment with 200 mg/kg to male and female animals caused transient salivation after dosing, reduction in body weight gain, and squamous hyperplasia of the forestomach. The forestomch lesion was also observed in males given 50 mg/kg.

Furthermore, treatment did not affect their reproductive abilities, including the estxous cycle, mating, parturition and reproductive Organ morphology.

Effect levels (P0)

1

Dose descriptor:

NOEL

Remarks:

systemic toxicity

Effect level:

12.5 - 50 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: The treatment with 200 mg/kg to male and female animals caused transient salivation after dosing, reduction in body weight gain, and squamous hyperplasia of the forestomach. The forestomch lesion was also observed in males given 50 mg/kg

2

Dose descriptor:

NOEL

Remarks:

fertility

Effect level:

>= 200 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: treatment did not affect their reproductive abilities, including the estxous cycle, mating, parturition and reproductive Organ morphology.

Results: F1 generation

Details on results (F1)

Growth retardation of offspring from birth in the 200 mg/kg-treated group indicated adverse effects of the test substance on pregnancy and lactation of dams or on pre- and postnatal growth of offspring. In addition, teratogenicity could not be excluded from slight increase in external malformations in this group.

Effect levels (F1)

Dose descriptor:

NOEL

Remarks:

developmental toxicity / teratogenicity

Generation:

F1

Effect level:

50 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: Growth retardation of offspring from birth in the 200 mg/kg-treated group; in addition, teratogenicity could not be excluded from slight increase in external malformations in this group

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

-