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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Referred in a recognized source of peer reviewed scientific data on chemicals

Data source

Reference
Reference Type:
review article or handbook
Title:
A 2-generation reproductive toxicity study of n-butylbenzene in rats.
Author:
Izumi H, Kimura E, Ota T, and Shimazu S
Year:
2005
Bibliographic source:
J. Tox. Sci. 30:21-38.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
n-Butylbenzene
IUPAC Name:
n-Butylbenzene

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Study observed:

Parental toxicity:

No substance-related mortality was observed.

Clinical signs:

At >=100 mg/kg bw: Salivation (males/females, both F0 and F1).

 

Organ weights:

At >=30 mg/kg bw/day: increased liver weights (F0 females).

At >=100 mg/kg bw/day: increased liver weights (F0 females).

At 300 mg/kg bw/day: increased liver weights (F1 males/females).

 

At 300 mg/kg bw/day: increased kidney weights (F0 males/females).

At >=100 mg/kg bw/day: increased liver weights (F1 males).

At 300 mg/kg bw/day: increased kidney weights (F1 females).

 

Histopathology:

At 300 mg/kg bw/day: centrilobular hepatocytic hypertrophy (F0 and F1 males).

At >=100 mg/kg bw/day: histopathological changes oft he kidney (F0 and F1 males).

 

NOEL (parental) < 30 mg/kg bw/day;

NOAEL/LOEL (parental) =30 mg/kg bw/day (increased liver weights)

LOAEL (parental) =100 mg/kg bw/day (increased kidney weights and histopathological changes in the kidney).

 

Reproductive Toxicity:

 

No substance-related effects on fertility were observed in F0 and F1 parental animals (males/females).

 

No substance-related effects on the endocrine system were observed.

 

NOEL and NOAEL (reproductive) =300 mg/kg bw/day

 

Developmental Toxicity:

 

At 300 mg/kg bw/day: increased absolute and relative weights of the thymus (F1 and F2 offspring animals).

 

NOEL and NOAEL (developmental) =100 mg/kg bw/day

 

LOAEL (developmental)= 300 mg/kg bw/day (increase in the thymus weights seen in F1 and F2 offspring)

Applicant's summary and conclusion

Conclusions:
Butylbenzene is not considered as being toxic to reproduction and/or developmental toxicant.