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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar to current OECD TG, limitations in monitoring of exposure conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
limitations in monitoring of exposure conditions
Principles of method if other than guideline:
Inhalation Hazard Test
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dihydrorosenoxid
- Physical state: liquid/colourless
- Analytical purity: 95.6%
- Lot/batch No.: 34-0773
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 8 - 9 weeks old
- Weight at study initiation: mean: females: 189 g, males: 276 g
- Housing: single
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The product was introduced to a height of 5 cm into a glass bottle (generator) with a sintered glass disk (pore-size 90 - 150 µm, diameter 30 mm), and the weight was determined. The generator containing the product was placed in a waterbath maintained at 20°C by a thermostat, and a stream of 200 L/h compressed air was bubbled through the generator. The mixture of air and test substance generated in this way was passed through a glass distributor to 6 glass tubes in which 3 male and 3 female animals had been placed. The emerging mixtures of test substance and air were exhausted. After 30 minutes, the generator was replaced by a new one containing fresh test substance as described above. This generator was then used for the remainder of the test. The substance in the generator was consumed after 6 hours.
Analytical verification of test atmosphere concentrations:
no
Remarks:
A nominal concentration was calculated from the amount of test substance consumed and the air volume.
Duration of exposure:
7 h
Concentrations:
23.1 mg/L
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical examinations were recorded for each animal several times during exposure and at least once on each workday in the observation period. Lethality was checked each day. Body weight was measured on day of exposure, day 7 and day 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: IHT
Effect level:
23.1 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
7 h
Remarks on result:
other: no deaths occured
Mortality:
No mortality occured.
Clinical signs:
other: At the beginning of exposure the animals showed eyelid closure and accelerated respiration. No clinical symptoms were observed post exposure.
Body weight:
No influence on body weight could be detected over the whole study period.
Gross pathology:
During necropsy no macroscopic pathologic findings were noted.

Applicant's summary and conclusion