Butanal, reaction products with aniline

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline No. 407

Principles of method if other than guideline:

Butanal, Reaction Products with Aniline was administered by gavage to 5 male and 5 female Wistar (HsdRCCHan) rats per dose group in daily doses of 0, 25, 100 or 400 mg/kg body weight for a period of at least 32 days. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done. At the end of the treatment period all animals were killed and a gross and microscopic examination of all major organs, including reproductive organs was conducted. The pathologic evaluation consisted of organ weight, gross and microscopic examination of reproductive organs, incl. testes, epidiymides, prostate, seminal vesicle coagulation gland, ovaries, and uterus.

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Butanal, reaction products with aniline

EC Number:

270-109-8

EC Name:

Butanal, reaction products with aniline

Cas Number:

68411-20-1

IUPAC Name:

aniline; butanal

Test material form:

other: liquid

Details on test material:

Test Substance/Item
Test Item Butanal, reaction products with aniline
Aniline content 0,4%
CAS No. 68411-20-1
EC-No. 270-109-8
Chemical name Butanal, reaction products with aniline
CAS name Butanal, reaction products with aniline
Purity 96,6% (taken as 100%)
Appearance Liquid, yellow
Storage Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Duration of treatment / exposure:

At least 32 days

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 25, 100 or 400 mg/kg body weight
Basis:
other: nominal

No. of animals per sex per dose:

5 male and 5 female rats/dose

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

400 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Remarks on result:

other:

Remarks:

No evidence of toxicity to reproductive was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOAEL, rat: 400 mg/kg bw/day).

Any other information on results incl. tables

There were no test substance-related toxic changes in organs weights of testes, epididymides, prostate, semical vesicle coagulation gland, ovaries, and uterus. No histopathological changes were found in testis, epididymides, prostate, seminal vesicle coagulation gland, ovaries and uterus.

Applicant's summary and conclusion

Conclusions:

No evidence of toxicity to reproductive was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOAEL, rat: 400 mg/kg bw/day).

Executive summary:

Butanal, Reaction Products with Aniline was administered by gavage to 5 male and 5 female Wistar (HsdRCCHan) rats per dose group in daily doses of 0, 25, 100 or 400 mg/kg body weight for a period of at least 32 days. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done. At the end of the treatment period all animals were killed and a gross and microscopic examination of all major organs, including reproductive organs was conducted. The pathologic evaluation consisted of organ weight, gross and microscopic examination of reproductive organs, incl. testes, epidiymides, prostate, semical vesicle coagulation gland, ovaries, and uterus.

No evidence of toxicity to reproductive was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOAEL, rat: 400 mg/kg bw/day).