Registration Dossier

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:
other: Study on read-across substance conducted using OECD Testing Guideline 403.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(Inhalation hazard test described in the Annex V; adopted 1981)
Deviations:
yes
Remarks:
observation period of 7 days
Principles of method if other than guideline:
Standardized test method (BASF-Test): The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at 20°C. Young adult laboratory rats, 3 per sex, were exposed sequentially to the vapours generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The exposure was subsequently repeated in the same manner. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period.
GLP compliance:
no
Test type:
other: inhalation risk test
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
other: Solid
Details on test material:
Chemical name : 4,4'-isopropylidenediphenol, ethoxylated
EC number : 500-082-2

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

Rats were exposed for 8 h to a vapour saturated atmosphere. Vapour was generated by bubbling 200 l/h air through the liquid substance column (volume ca. 50 mL) of about 5 cm above a fritted glass disc in a glass cylinder. The air pressure was 754 mm Hg. Temperature in the exposure chamber was 20°C. Concentration was stated in the raw data to be 0.021 mg/L in the case of the 8 h exposure.

TEST ATMOSPHERE

Brief description of analytical method used: no analytics performed
Samples taken from breathing zone: no



Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
No verification of the concentration was performed. Nominal concentration: 0.021 mg/L
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
Duration of observation period following administration: 7 days
Frequency of observations and weighing: group wise documentation on working days
Necropsy of survivors performed: yes
Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: IHT
Effect level:
0.021 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No mortality.
Mortality:
No mortality observed.
Clinical signs:
other:
Gross pathology:
No abnormality detected.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The IHT was given as 0.021 mg/L (air). No deaths or abnormalities were recorded. The substance vapours were not toxic at the maximum achievable test concentrations.
Executive summary:

The acute inhalation toxicity of the test substance to rats (strain not specified) was determined in accordance with the OECD Guideline for Testing of Chemicals 403. The rat was exposed to a whole body dose, nominally stated as 0.021 mg/L. The IHT was given as 0.021 mg/L (air). The animals were observed for 7 days. No deaths or abnormalities were recorded. The substance vapours were not toxic at the maximum achievable test concentrations.