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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline 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:
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

Constituent 1
Reference substance name:
Alcohols, C9-11 ethoxylated, < 2.5 EO
EC Number:
614-482-0
Cas Number:
68439-46-3
Molecular formula:
not applicable, UVCB
IUPAC Name:
Alcohols, C9-11 ethoxylated, < 2.5 EO
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
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
Remarks:
Doses / Concentrations:
0, 1, 10, 25%
Basis:
nominal in water
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

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.

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
Remarks on result:
other: Generation: P, F1 (migrated information)
Dose descriptor:
NOAEL
Remarks:
dev tox
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Remarks on result:
other: Generation: F1, F2 (migrated information)
Dose descriptor:
NOEL
Remarks:
systemic
Effect level:
100 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Remarks on result:
other: Generation: P, F1 (migrated information)
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.
Remarks on result:
other: Generation: P, F1 (migrated information)

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)

Dose descriptor:
NOAEL
Remarks:
systemic
Generation:
F1
Effect level:
>= 250 mg/kg bw/day
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: Changes in body weight and organ weights without associated pathological findings.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion