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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
Oral route, rat or rabbit
Deviations:
yes
Remarks:
In the Study plan, it was assumed female fertilisation by insemination, however in the premilinary stage of the test it was decided to introduce fertilization by method of male mating. The change does not affectthe test results.

Test material

Constituent 1
Test material form:
solid: flakes

Test animals

Species:
rabbit
Strain:
New Zealand White

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

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Dose descriptor:
LOAEL
Effect level:
45 mg/kg bw/day
Basis for effect level:
food consumption and compound intake
water consumption and compound intake
Dose descriptor:
LOAEL
Effect level:
> 160 mg/kg bw/day
Basis for effect level:
body weight and weight gain
Key result
Dose descriptor:
NOAEL
Effect level:
10 mg/kg bw/day
Basis for effect level:
food consumption and compound intake
water consumption and compound intake

Maternal abnormalities

Abnormalities:
effects observed, treatment-related
Localisation:
uterus
Description (incidence and severity):
the weight of the pregnant uterus showed a statistically significant decrease of 39.5% compared to the control group in the case of animals in the 160 mg/kg b.w.

Results (fetuses)

Effect levels (fetuses)

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Dose descriptor:
LOAEL
Effect level:
160 mg/kg bw/day
Basis for effect level:
other: Viable fetuses
Dose descriptor:
NOAEL
Effect level:
45 mg/kg bw/day
Basis for effect level:
other: Viable fetuses
Dose descriptor:
LOAEL
Effect level:
> 160 mg/kg bw/day
Basis for effect level:
other: Number of corpora lutea
Dose descriptor:
LOAEL
Effect level:
> 160 mg/kg bw/day
Basis for effect level:
other: Average number of embryonic deaths
Dose descriptor:
LOAEL
Effect level:
45 mg/kg bw/day
Sex:
male/female
Basis for effect level:
fetal/pup body weight changes
Key result
Dose descriptor:
NOAEL
Effect level:
10 mg/kg bw/day
Sex:
male/female
Basis for effect level:
fetal/pup body weight changes

Fetal abnormalities

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Abnormalities:
effects observed, non-treatment-related
Localisation:
other: Developmental alterations in osteochondral system
Description (incidence and severity):
Parcial or no ossification of 5 bones of sternum and xiphoid cartilage
Abnormalities:
no effects observed
Localisation:
other: Developmental defects in osteochondral system
Abnormalities:
no effects observed
Localisation:
other: Changes in soft tissue and encephalon

Overall developmental toxicity

Key result
Developmental effects observed:
no

Any other information on results incl. tables

As no developmental disorders were found, this may suggest a mechanism related to maternal toxicity of the 2,4,6-trinitrotoluene.

Applicant's summary and conclusion