Registration Dossier
Registration Dossier
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EC number: 442-490-2 | CAS number: 871-70-5 EMEROX 118
Toxicity to reproduction
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- IUPAC Name:
- docosanoic acid
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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