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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
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: see 'Remark'
Remarks:
GLP-Guideline Study, tested with the source substance CAS 112-85-6. In accordance to ECHA guidance document "Practical guide 6: How to report read-across and categories (May 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Docosanoic acid
- Physical state: white powder
- Analytical purity: 85.9 %
- Lot/batch No.: 60805X
- Impurities (identity and concentrations): C14-C20 fatty acids: 10.9 %, C24 fatty acids: 2.3 %
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on mating procedure:
- M/F ratio per cage: 1/1
- Length of cohabitation: up to two weeks
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Further mating after two unsuccessful attempts: no
- After successful mating each pregnant female was caged (how): individually
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
- males: 42 days
- females: from 14 days prior to mating to day 3 of lactation
Frequency of treatment:
daily
Details on study schedule:
- Age at mating of the mated animals in the study: 10 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
100, 300, 1000 mg/kg bw/d
Basis:
nominal conc.
No. of animals per sex per dose:
13 in each group
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse substance -related findings on fertility were noted

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Table 1. Summary of development up of pups from dams treated orally with docosanoic acid in the combined repeat dose and reproductive/developmental toxicity screening test: Mean± S.D (N)

Dose group (mg/kg)

0

100

300

1000

Number of pregnant females

13

12

12

13

Number of pregnant females with live pups

13

12

12

13

Gestation index

100

100

100

100

Gestation length in days

22.2±0.4 (13)

22.4±0.5 (12)

22.3±0.5 (12)

22.2±0.4 (13)

Number of corpora lutea

16.6±1.6 (13)

16.7±1.8 (12)

16.8±2.3 (12)

16.2±1.5 (13)

Number of implantation sites

16.1±1.5 (13)

15.8±2.1 (12)

16.0±1.5 (12)

15.2±3.1 (13)

Implantation index

96.9±5.1 (13)

94.8±7.1 (12)

96.1±6.0 (12)

93.1±15.2 (13)

Day 0 of lactation

 

 

 

 

Number of pups born

15.2±1.6 (13)

14.8±2.2 (12)

15.2±1.5 (12)

14.3±2.7 (13)

Delivery index

94.5±8.0 (13)

93.5±3.9 (12)

94.9±4.3 (12)

94.9±6.2 (13)

Number of live pups

14.9±1.6 (13)

14.3±2.2 (12)

15.1±1.6 (12)

14.1±2.7 (13)

Birth index

93.1±8.8 (13)

90.7±8.7 (12)

94.3±5.1 (12)

93.5±7.2 (13)

Live birth index

98.5±2.8 (13)

97.0±8.5 (12)

99.4±2.2 (12)

98.5±4.0 (13)

Sex ration on day 0

50.0±11.3 (13)

46.7±9.8 (12)

54.8±12.3 (12)

48.9±13.4(13)

Day 4 of lactation

 

 

 

 

Number of live pups

14.7±1.4 (13)

13.0±4.7 (12)

15.1±1.6 (12)

14.1±2.7 (13)

Viability index

98.6±2.7 (13)

89.4±28.8 (12)

100.0±0.0 (12)

100.0±0.0 (13)

Sex ration on day 4

49.8±11.5 (13)

46.3±10.3 (11)

54.8±12.3 (12)

48.9±13.4(13)

Applicant's summary and conclusion