Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was not conducted to a specific test guideline, no claim of GLP complaince was included in the test report, and the level of detail provided in the report was lacking for certain aspects or the study, so the study cannot be considered reliable without restrictions. The methodology described does, however, seem essentialy reliable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Five male and five female rats were exposed to an atmosphere containing the test material for 4 hours. During the exposure period the rats were observed for changes in appearance or behaviour, and after the exposure period they were observed for pharmacodynamic or toxic signs. The rats were observed for 14 days following the exposure period, then any surviving animals were sacrificed.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzoflex 2-45
- Physical state: Pale yellow liquid

Test animals

Species:
rat
Strain:
other: Spartan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: 208 to 262 g
- Housing: Rats were housed in groups of 5 in metal cages above the droppings.
- Diet (e.g. ad libitum): Purina Laboratory Chow was available ad libitum
- Water (e.g. ad libitum): Water was available ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature was controlled (note that the temperature range was not reported)
- Humidity (%): Humidity was controlled (note that the humidity range was not reported)

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:Sealed glass chamber, test material addition controlled by a Dual Syringe Feeder.
- Exposure chamber volume: 59.1 L

TEST ATMOSPHERE
- Brief description of analytical method used: None reported



Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
Calculated to be 200 mg/L of DEGDB.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the 4 hour exposure to the test compound the rats were observed continuously for changes in behavior and or appearance.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 200 mg/L air
Exp. duration:
4 h
Remarks on result:
other: No deaths seen during exposure or observation periods.
Mortality:
All the rats exposed to DEGDB for the 4-hour exposure duration survived until the end of the observation period.
Clinical signs:
During the exposure period, decreased motor activity, eye squint, salivation, lacrimation, and nasal porphyrin discharge.
At 24, 48, and 72 hours after the end of the exposure duration, decreased motor activity was observed with the addition of salivation at 24 hours.
Body weight:
All rats exhibited normal body weight gains during the study.
Gross pathology:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information According to Directive 67/548/EEC Criteria used for interpretation of results: EU
Conclusions:
No deaths were seen in rats exposed to a 200 mg/L atmosphere of DEGDB in air for four hours. On this basis, DEGDB would not be considered a toxic material by the inhalation route of administration.
Executive summary:

A package of acute toxicity testing (including oral, inhaled, and dermal toxicity assessment) was conducted to assess the acute toxicity characteristics of the test substance DEGDB.

The acute inhaled toxicity assessment was performed in groups of five female and five male albino rats, exposed to an atmosphere containing the test material for four hours, then observed for 14 days post exposure.

None of the rats exposed to the test material died during the course of the observation period. On this basis, DEGDB would not be considered a toxic material by the inhalation route of administration.