Registration Dossier
Registration Dossier
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EC number: 500-165-3 | CAS number: 66455-14-9 1 - 2.5 moles ethoxylated
Toxicological information
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive 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:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Remarks:
- Only 3 applications per week; no or only partial examination of oestrous cycle and sperm parameters.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 68439-46-3
- EC Number:
- 614-482-0
- Cas Number:
- 68439-46-3
- IUPAC Name:
- 68439-46-3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- 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
- Details on mating procedure:
- As described in guideline.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- No data.
- Frequency of treatment:
- 3/week (except during mating)
- Details on study schedule:
- P: 119 days of dosing
F1: 133 days of dosing
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: % nominal in water
- Dose / conc.:
- 1 other: % nominal in water
- Dose / conc.:
- 10 other: % nominal in water
- Dose / conc.:
- 25 other: % nominal in water
- Dose / conc.:
- 0 other: mg/kg bw nominal in water
- Dose / conc.:
- 10 other: mg/kg bw nominal in water
- Dose / conc.:
- 100 other: mg/kg bw nominal in water
- Dose / conc.:
- 250 other: mg/kg bw nominal in water
- No. of animals per sex per dose:
- 30 (P)
20/40 (male/female; F1) - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- As described in guideline.
- Oestrous cyclicity (parental animals):
- Not examined.
- Sperm parameters (parental animals):
- Weight and histopathology are missing.
- Litter observations:
- No individual weighing of pups.
- Postmortem examinations (parental animals):
- As described in guideline.
- Postmortem examinations (offspring):
- As described in guideline.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
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.
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 (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- reprotox
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed.
- Dose descriptor:
- NOAEL
- Remarks:
- dev tox
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed.
- Dose descriptor:
- NOEL
- Remarks:
- systemic
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in body weight and organ weights without associated pathological findings.
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in body weight and organ weights without associated pathological findings.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- reprotox
- Generation:
- F1
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed.
- Dose descriptor:
- NOEL
- Remarks:
- systemic
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in body weight and organ weights without associated pathological findings.
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Generation:
- F1
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in body weight and organ weights without associated pathological findings.
- Dose descriptor:
- NOAEL
- Remarks:
- dev tox
- Generation:
- F1
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed.
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Remarks:
- dev tox
- Generation:
- F2
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
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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