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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (403): pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
No analytical concentration measurements.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: mouse, rat, and guinea pig
Strain:
other: Swiss, Wistar, and Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data provided
- Age at study initiation: no data provided
- Weight at study initiation: no data provided
- Fasting period before study: 3-4 hours
- Housing: groups
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel gassing chamber
- Exposure chamber volume: 500 l
- Method of holding animals in test chamber: n/a
- Source and rate of air: forced room air
- Method of conditioning air: glass bubblers
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
6 h
Concentrations:
3 mg/l nominal concentration
No. of animals per sex per dose:
10 males per species
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) Every 30 minutes during exposure and daily thereafter for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
No data analyzed.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
> 3 mg/L air (nominal)
Exp. duration:
6 h
Remarks on result:
other: mice and rats
Sex:
male
Dose descriptor:
LC50
Effect level:
< 3 mg/L air (nominal)
Exp. duration:
6 h
Remarks on result:
other: guinea pig
Mortality:
2 guinea pigs died on the 2nd day, 1 on the 13th, and 2 on the 14th post exposure.
All mice and rats survived.
Clinical signs:
other: No significant signs of respiratory irritation were noted. Alopecia and some weight loss were noted in the guinea pigs during the 14-day observation period.
Body weight:
Not analyzed.
Gross pathology:
No significant findings.

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation LC50 for isononanol is >3 mg/l for mice and rats.
Executive summary:

Neodecanoic acid was administered via a vapor inhalation to 10 each of mice, rats, and guinea pigs at the nominal concentration of 3 mg/l for 6 hours.  Clinical observations were made every 30 minutes during the exposure and daily thereafter for 14 days.  No significant signs of respiratory irritation were noted.  Alopecia and some weight loss were noted in the guinea pigs during the 14-day observation period.  Two guinea pigs died on the 2nd day, 1 on the 13th, and 2 on the 14th post exposure.  All mice and rats survived.  Based on these data it is concluded that the LC50 for mice and rats is greater than 3 mg/l.