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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

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)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
EC Number:
269-348-0
EC Name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
Cas Number:
68227-33-8
Molecular formula:
C16H30O2
IUPAC Name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
Constituent 2
Reference substance name:
269-384-0
IUPAC Name:
269-384-0
Constituent 3
Reference substance name:
2,5,8,11-tetramethyl-6-dodecyne-5,8-diol
IUPAC Name:
2,5,8,11-tetramethyl-6-dodecyne-5,8-diol
Test material form:
other: waxy solid
Details on test material:
batch# 20702

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
GC
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
50 mg/kg/day
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
100 mg/kg/day
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
200 mg/kg/day
Basis:
nominal in diet
No. of animals per sex per dose:
10 animals per sex and dose
Control animals:
yes, plain diet

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Description (incidence and severity):
The clinical observations detected during this study were not considered to be related to systemic toxicity.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No adverse effect on bodyweight development or bodyweight gain was detected.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No adverse effect on bodyweight development or bodyweight gain was detected.
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
Histopathogical examinations revealed the following treatment-related effect:
Other effects:
no effects observed
Description (incidence and severity):
Test substance intake: No adverse effect on bodyweight development or bodyweight gain was detected.

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Description (incidence and severity):
No treatment-related effects were detected in the length of gestation.
Reproductive function: sperm measures:
no effects observed
Description (incidence and severity):
No treatment-related effects were detected in mating performance or fertility.
Reproductive performance:
no effects observed
Description (incidence and severity):
No treatment-related effects were detected in mating performance or fertility.

Effect levels (P0)

open allclose all
Key result
Dose descriptor:
NOEL
Effect level:
125 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: see 'Remark'
Key result
Dose descriptor:
NOAEL
Effect level:
125 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: see 'Remark'

Target system / organ toxicity (P0)

Critical effects observed:
no

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Mortality / viability:
no mortality observed
Description (incidence and severity):
No significant differences were detected in litter sizes, sex ratio and viability for treated groups when compared to controls.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Sexual maturation:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Gross pathological findings:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Histopathological findings:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.

Effect levels (F1)

Key result
Dose descriptor:
NOEL
Generation:
F1
Effect level:
125 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
sexual maturation
clinical signs
mortality
body weight and weight gain
organ weights and organ / body weight ratios
gross pathology

Target system / organ toxicity (F1)

Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
No treatment-related effects were detected in the reproductive parameters measured, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 125 mg/kg/day.