Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Report on the Safety Assessment of the given test chemical.
Author:
COSMETIC INGREDIENT REVIEW
Year:
2006
Bibliographic source:
International Journal of Toxicology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute Inhalation Toxicity study of the given test chemical in rats.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
o-cresol
EC Number:
202-423-8
EC Name:
o-cresol
Cas Number:
95-48-7
Molecular formula:
C7H8O
IUPAC Name:
O-cresol
Details on test material:
- IUPAC Name: o-cresol
- Mol. formula: C7H8O
- Molecular Weight:108.139 g/mole
- InChI: 1S/C7H8O/c1-6-4-2-3-5-7(6)8/h2-5,8H,1H3
- Smiles: c1(c(cccc1)O)C
- Physical state: Solid or liquid with a phenolic odor

Test animals

Species:
rat
Strain:
other: albino rats (FDRL/Wistar stock)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: weighing between 200 and 300 g

Administration / exposure

Route of administration:
inhalation: mist
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: The atomizer used delivered a very fine mist

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: the particle size was not stated
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Concentrations:
0.2, 2.0, or 20.0 mg/L
No. of animals per sex per dose:
three groups of five males and five females per group
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 20 mg/L air
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: No mortality was observed in the study.
Mortality:
No rats died in the study.
Clinical signs:
other: Eye irritation was observed during the exposure period and these effects cleared within 24 h.
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute inhalation LC50 was considered to be >20 mg/L when male and female albino rats were treated with the given test chemical via inhalation route for 6 hours exposure period.
Executive summary:

Acute inhalation toxicity study was conducted by using the given test chemical in albino rats. Thirty albino rats (FDRL/Wistar stock) weighing between 200 and 300 g were distributed into three groups of five males and five females per group. The atomizer used delivered a very fine mist but the particle size was not stated. Rats were exposed at either 0.2, 2.0, or 20.0 mg/L of aerosolized chemical for 6 h. Observations were made daily for 14 days after the exposure. No rats died in the study, but eye irritation was observed during the exposure period and these effects cleared within 24 h. Under the condition of this, the acute inhalation LC50 was considered to be >20 mg/L when male and female albino rats were treated with the given test chemical via inhalation route for 6 hours exposure period.