Isopropyl benzoate

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This is a summary of studies reviewed by the expert groups of the OECD High Production Volume (HPV) Chemicals Programme (SIDS Review Committee) and the U.S. Cosmetic Ingredient Review Expert Panel (CIR), which accepted the data as scientifically valid.

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

SIDS Initial Assessment Profile, 2-Propanol (CAS No: 67-63-0)

Author:

OECD

Year:

1997

Bibliographic source:

SIAM 6, http://www.chem.unep.ch/irptc/sids/OECDSIDS/67630.pdf

Report date:

1997

Reference 2

Reference Type:

review article or handbook

Title:

Safety assessment of alkyl benzoates as used in cosmetics

Author:

Becker LC, Bergfeld WF, Belsito DV, et al.

Year:

2012

Bibliographic source:

Int. J. Toxicol. 31:342S-72S

Reference 3

Reference Type:

publication

Title:

Isopropyl alcohol 13-week vapour inhalation study in rats and mice with neurotoxicity evaluation in rats.

Author:

Burleigh-Flayer HD, Gill MW, Strother DE, et al.

Year:

1994

Bibliographic source:

Fundam. Appl. Toxicol 23(3): 421-428.

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA OPPTS 870.4300

Principles of method if other than guideline:

This is a summary of a study reviewed by the OECD HPV Programme (SIDS) and the U.S. CIREP. The study was performed under US EPA TSCA guideline for a combined repeated dose toxicity/carcinogenicity.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propan-2-ol

EC Number:

200-661-7

EC Name:

Propan-2-ol

Cas Number:

67-63-0

IUPAC Name:

propan-2-ol

Constituent 2

Reference substance name:

isopropanol

IUPAC Name:

isopropanol

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

6 hours per day, 5 days per week

Doses / concentrations

Remarks:

Doses / Concentrations:
1230, 3690 and 12300 mg/m3
Basis:

No. of animals per sex per dose:

10

Control animals:

yes

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

narcosis at 3690 and 12300 mg/m3, ataxia at 12300 mg/m3. No exposure-related mortality.

Mortality:

mortality observed, treatment-related

Description (incidence):

narcosis at 3690 and 12300 mg/m3, ataxia at 12300 mg/m3. No exposure-related mortality.

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

transient decreases in body weight at the highest dose at the end of the first week.

Gross pathological findings:

effects observed, treatment-related

Description (incidence and severity):

Hyaline droplets in the kidneys of all male rats (including controls). The size and frequency were increased in exposed groups.

Details on results:

Adverse effects observed at the LOAEC (3690 mg/m3) included narcosis in rats and mice, hematological changes in rats and increased liver weights in mice. Hyaline droplets in the kidneys of all male rats (including controls) were observed histopathologically. The size and frequency of the hyaline droples were increased in exposed groups; the biological significance is unknown.

Effect levels

Key result

Dose descriptor:

NOAEC

Effect level:

1 230 mg/m³ air

Based on:

test mat.

Sex:

male/female

Basis for effect level:

histopathology: non-neoplastic

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Isopropyl alcohol vapour was administered to male and female Fisher 344 rats and CD-1 mice for 6 hours per day, 5 days per week, for 13 weeks. THe NOAEC was 1230 mg/m3. At higher concentrations, rats exhibited narcosis, an increase in renal hyaline droplets and hematological effects. This study is informative for evaluation of the toxicity and environmental fate of members of the Alkyl Benzoates category, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.