Alcohols, C12-18, ethoxylated

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to Guideline study with acceptable restrictions (non-GLP).

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD 416

Deviations:

yes

Remarks:

Only 3 applications per week; no or only partial examination of oestrous cycle and spermatogenicity.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

68439-46-3

EC Number:

614-482-0

Cas Number:

68439-46-3

IUPAC Name:

68439-46-3

Details on test material:

- Name of test material (as cited in study report): trade name
- Ethoxylation degree: 6
- Physical state: Clear, non-viscous liquid
- Analytical purity: No data
- Lot/batch No.: 423E
- Storage condition of test material: No data

Test animals

Species:

rat

Strain:

Fischer 344

Details on test animals or test system and environmental conditions:

As described in guideline.

Administration / exposure

Route of administration:

dermal

Vehicle:

water

Details on exposure:

Dose volume: 1 mL/kg bw

Analytical verification of doses or concentrations:

yes

Details on mating procedure:

As described in guideline.

Duration of treatment / exposure:

No data.

Frequency of treatment:

3/week (except during mating)

Duration of test:

From Day 0 of gestation until weaning.

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0, 1, 10, 25%
Basis:
nominal in water

Doses / concentrations 2

Remarks:

Doses / Concentrations:
0, 10, 100, 250 mg/kg bw
Basis:
nominal in water

No. of animals per sex per dose:

30 (P)
20/40 (male/female; F1)

Control animals:

yes, concurrent vehicle

Examinations

Maternal examinations:

As described in guideline.

Ovaries and uterine content:

As described in guideline.

Fetal examinations:

As described in guideline.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:yes

Details on maternal toxic effects:
In the highest dose, body weights of both males and females in both treated generations were sporadically and not always statistically significant decreased compared to controls.
At necropsy organ weight differences in liver, lung, kidney and heart were observed in the F1 generation, but no pathological findings were associated with the affected organs.

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

>= 250 mg/kg bw/day (nominal)

Based on:

act. ingr.

Basis for effect level:

other: developmental toxicity

2

Dose descriptor:

NOEL

Effect level:

100 mg/kg bw/day (nominal)

Based on:

act. ingr.

Basis for effect level:

other: maternal toxicity

3

Dose descriptor:

NOAEL

Effect level:

>= 250 mg/kg bw/day (nominal)

Based on:

act. ingr.

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified