Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
other: read across
Title:
Unnamed
Year:
2010
Reference Type:
publication
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
read across
GLP compliance:
no

Test material

Constituent 1
Details on test material:
read across

Test animals

Species:
rat
Strain:
Brown Norway

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Details on results:


Kidney Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)
Liver Pathology and Weight ; First generation adult parental animals( P1)
Liver Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)
Kidney Pathology and Weight ; First generation adult parental animals( P1)
Decrease in Implantations ; First generation adult parental animals( P1)
Decrease in Implantations ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)
Decreased Litter Size ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)
Ovary Pathology and Weight ; First generation adult parental animals( P1)
Ovary Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)
Kidney Pathology and Weight ; First generation adult parental animals( P1)
Kidney Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)
Liver Pathology and Weight ; First generation adult parental animals( P1)
Liver Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)

Effect levels (maternal animals)

Remarks on result:
not measured/tested

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
LOEL
Effect level:
665 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Kidney Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)

Liver Pathology and Weight ; First generation adult parental animals( P1)

Liver Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)

Kidney Pathology and Weight ; First generation adult parental animals( P1)

Decrease in Implantations ; First generation adult parental animals( P1)

Decrease in Implantations ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)

Decreased Litter Size ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)

Ovary Pathology and Weight ; First generation adult parental animals( P1)

Ovary Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)

Kidney Pathology and Weight ; First generation adult parental animals( P1)

Kidney Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)

Liver Pathology and Weight ; First generation adult parental animals( P1)

Liver Pathology and Weight ; Second generation adult parental animals or first generation juvenile (young) offspring from P1 adult animals (specific to effect)( F1)

Applicant's summary and conclusion