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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP and did not follow specific OECD test guidelines. However, it was an acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Type: other: Two generation study Method: other: see below
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
EC Number:
701-028-2
Cas Number:
26523-78-4
Molecular formula:
C45H69O3P
IUPAC Name:
4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
Constituent 2
Reference substance name:
Nonylphenol
EC Number:
246-672-0
EC Name:
Nonylphenol
Cas Number:
25154-52-3
IUPAC Name:
2-nonylphenol

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Duration of treatment / exposure:
2 years
Doses / concentrations
Remarks:
Doses / Concentrations:Designed to be equivalent to approximately 1000, 3300, and 10,000 ppm in the diet when the rats reached maturity (0, 50, 167, and 500 mg/kg/day) Basis:nominal in diet
No. of animals per sex per dose:
200 weanling rats were distributed into four groups of 25 males and 25 females each.
Control animals:
yes, concurrent no treatment
Details on study design:
See discussion below.

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:
no effects observed
Reproductive function: sperm measures:
no effects observed

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
3 300 ppm
Sex:
male/female
Basis for effect level:
other: No adverse effects observed

Results: F1 generation

General toxicity (F1)

Mortality / viability:
mortality observed, treatment-related

Results: F2 generation

Effect levels (F2)

Dose descriptor:
NOAEL
Generation:
F2
Effect level:
3 300 ppm
Based on:
test mat.
Remarks:
(equivalent to 167 mg/kg/day)
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based on those results, indicating a possible effect at the dose of 500 mg/kg/d, a NOAEL from this study was 167 mg/kg bw/day (3300 ppmin diet).
Executive summary:

Based on those results, indicating a possible effect at the dose of 500 mg/kg/d, a NOAEL from this study was 167 mg/kg bw/day (3300 ppmin diet).