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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
repeated dose toxicity: oral
Remarks:
combined repeated dose and reproduction / developmental screening
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:
according to guideline
Guideline:
other: Two-Generation Reproductive Toxicity Study in Rats
Principles of method if other than guideline:
Two-Generation Reproductive Toxicity Study in Rats
GLP compliance:
not specified

Test material

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

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

28-Day Oral Toxicity Study (Preliminary study):

Study observed:

At 1000 mg/kg bw/day: inhibition of body weight gain (males/females).

At >=300 mg/kg bw/day: elevated liver and kidney/adrenal weights (males)

Two-Generation Reproductive Toxicity Study in Rats:

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:
Overall, the liver and kidney are reported as target organs for chronic toxicity of butylbenzene components. The chronic toxicity data observed in the repeated dose toxicity studies with rodents report the following NOAELs/LOAELs for n-butylbenzene:
NOAEL (oral, rats, systemic toxicity) =30 mg/kg bw/day (increased liver weights)
LOAEL (oral, rats, systemic toxicity) =100 mg/kg bw/day (increased kidney weights and histopathological changes in the kidney).