2-methylresorcinol

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Guideline:

other: OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Duration of treatment / exposure:

6 -20 days post coitum

Remarks:

Doses / Concentrations:
0/40/200/400 mg/kg/day
Basis:
nominal in diet

Dose descriptor:

NOAEL

Effect level:

400 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

female

Basis for effect level:

other: various

Remarks on result:

other: see attached study details

Remarks on result:

not measured/tested

Reproductive effects observed:

not specified

The test substance was given in propylene glycol daily at dose volumes of 10 ml/kg bw

by oral gavage. The doses were selected on the basis of the results of a preliminary

study in rats. Maternal evaluations and measurements included daily clinical signs and

body weight/food intake recorded at designated intervals.

The dams were sacrificed on day 21 post-coitum by carbon dioxide asphyxiation and

subjected to necropsy. The number of alive and dead foetuses, their distribution and site in

the uterus, early and late resorption, implantation and number of corpora lutea was

determined. The weight of the foetuses, gravid uteri, uteri without foetuses, placenta and

the sex of foetuses was recorded. The foetuses examined for visceral alterations. Alternate

foetuses were examined for skeletal malformations, variations and retardation of the normal

organogenesis after appropriate staining.

Results

No maternal toxicity was observed, as mortality, clinical appearance, body weights, food

consumption, and macroscopic examination were unaffected by exposure to the test

substance.

No reproductive toxicity was observed, as no effects were noted on pregnancy outcome,

post-implantation loss, litter size, and sex distribution.

No developmental toxicity was observed, as foetal body weights, placental weights, and

external, visceral and skeletal examination did not reveal any adverse effects of the test

substance.

Based on the results in this embryotoxicity and teratogenicity study, the No Observed

Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg

bw/day.

Comment

The dose levels were based on a range finding study. In this study severe clinical

effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the

effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw

on the second day of administration). It is remarkable that in the present study no

maternal toxicity was observed up to a dose level of 400 mg/kg bw/day.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

400 mg/kg bw/day

Study duration:

subacute

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Justification for classification or non-classification

At the found effect levels there is no requirement for classification