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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
one-generation reproductive toxicity
Remarks:
based on generations indicated in Effect levels (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Testing described in reputable secondary literature source.
Justification for type of information:
An OECD 422 test has been required by ECHA as outcome of Compliance Check under Article 41 REACH. This test has been commissioned, scoped, and is being scheduled by the laboratory.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Method not elaborated in secondary literature source.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-890-4
EC Name:
-
Cas Number:
82469-79-2
Molecular formula:
C28H50O8
IUPAC Name:
1,2,3-trihexyl 2-(butanoyloxy)propane-1,2,3-tricarboxylate

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
Males were exposed to BTHC continuously to BTHC for ten weeks prior to mating and during the mating period. Females were exposed for two weeks before mating, during mating, gestation and lactation.
Frequency of treatment:
Continuously

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:
other: No effects on fertility and other reproductive indices, or on litter weights and pup weights were observed. The kg bw/ of the lactating females exposed to the top dose was slightly lower.

Results: F1 generation

Effect levels (F1)

Dose descriptor:
other:
Generation:
F1
Basis for effect level:
other: No effects on fertility and other reproductive indices, or on litter weights and pup weights were observed. The kg bw/ of the lactating females exposed to the top dose was slightly lower. No increase in abnormalities in the F1 pups was found.
Remarks on result:
not measured/tested
Remarks:
Effect level not specified (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Reproductive studies.

A fertility study was carried out in albino rats at dietary levels of 0,0.6 0r 1.2% BTHC. Males were exposed to BTHC continuously

to BTHC for ten weeks prior to mating and during the mating period. Females were exposed for two weeks before mating, during

mating, gestation and lactation. No effects on fertility and other reproductive indices, or on litter weights and pup weights were

observed. The kg bw/ of the lactating females exposed to the top dose was slightly lower. No increase in abnormalities in the F1

pups was found.

Applicant's summary and conclusion

Conclusions:
(page 68) No effects of BHTC could be found in rats on reproductive efficiency nor were dose dependent foetal abnormalities or foetal deaths identified.