Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: In principle according to OECD 403, however analytical determination of the atmosphere concentration was not performed; the exposure time was 8h; method and results are poorly described in the report (however raw data are available)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
analytical determination, exposure time 8 h
GLP compliance:
no
Test type:
other: inhalation risk test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test-item: Golpanol SC 9269 = Golpanol ALS
- Purity: 25 % in aqua dest.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 238 g (male), 181,3 g (female)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 200 L air/h

TEST ATMOSPHERE
- Brief description of analytical method used: Inhalation of a vapour-saturated atmosphere at 20°C. For saturation air was disposed through a 5 cm thick product layer. The calculated vapour saturation for the a. i. is 0.00002 µg/L.

VEHICLE
- Composition of vehicle (if applicable): air
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
Concentration was stated to be 4.71 mg/L calculated reweighing of the product column after exposure. Due to the very low vapour pressure ( 3e-09 hPa at 25°C) / vapour saturation (0.00002 µg/L) of the a. i. it is assumed that this substance loss is mainly based on loss of water.
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was done on day 0 and day 7. No informations about observation times.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: IHT
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: Mortality: 0/12 animals died after exposure to a saturated vapour atmosphere.
Mortality:
0/12 died
Clinical signs:
other: Strong mucosa irritation, eyelid closure on the day of exposure. The first day after exposure there were no abnormalities detected anymore.
Body weight:
The mean body weights of the animals were in the normal range throughout the study period.
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion