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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
Study period:
1999/09/29-1999/10/22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
An 8hr exposure for 3 consecutive days, one day post-treatment observation
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: WAG/RijCrlBR
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deuschland, Sulzfeld, Germany
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 33-50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Test atmosphere was generated by pumping liquid C9-C11 cyclic aliphatic into stainless steel tubing using peristaltic pumps. The tubing was led through a water bath at 74 deg C and the resulting vapour was transported with an air stream from a compressed air source and added to the main airflow system. The test atmospheres were analysed by two total carbon analysers.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
total carbon analysers
Duration of exposure:
8 h
Concentrations:
0 (air), 1 g/m3 (170ppm), 2.5 g/m3 (430ppm), 5 g/m3 (860ppm)
No. of animals per sex per dose:
8 animals per dose
Control animals:
yes
Details on study design:
Animals were exposed to the test atmosphere in modified H100 inhalation chambers Hazleton System Inc., USA). Each chamber was fitted with a manometer that allowed monitoring the slightly negative pressure inside. Three test groups (with one control) comprising of 8 rats each were exposed to Nappar 10 at different concentrations including: 0 (air), 1 g/m3 (170ppm), 2.5 g/m3 (430ppm), 5 g/m3 (860ppm). Animals were exposed to the test atmosphere 8hours/day for 3 consecutive days. All rats were checked for health and viability at least once daily. Body weight was recorded during randomization on days of testing.
Statistics:
All data were analyzed using the SAS statistical software package (v. 6.12). For each test measure, probability of p<= 0.05 were considered significant.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 5 000 mg/m³ air (nominal)
Exp. duration:
8 h
Remarks on result:
other: no deaths noted after 3 consecutive days of exposure
Mortality:
All animals survived to the end of the study.
Clinical signs:
One animal (2.5 g/m3) and three animals (5.0 g/m3) were noted with bloody exudation around the nose and mouth after the third exposure.
Body weight:
No significant changes were noted after exposure.
Gross pathology:
N/A
Other findings:
N/A

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

C9 -C11 cyclic aliphatics were administered via individual inhalation chambers for eight hours to eight Sprague-Dawley rats at vapor concentration of 0 (air), 1 g/m3 (170ppm), 2.5 g/m3 (430ppm), 5 g/m3 (860ppm) for three consecutive days. There was no mortality noted in any of the animals.  Based on the conditions of this study, the LC50 for acute inhalation exposure to C9 -C11 cyclic aliphatics vapor is greater than the highest obtainable vapor concentration (5 g/m3).  Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.