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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Original tests performed according to an international guideline under GLP.
Justification for type of information:
Information based on safety assessment of lactate esters.

Data source

Reference
Reference Type:
review article or handbook
Title:
Safety Assessment of Lactate Esters
Author:
Clary J J, Feron V J and van Velthuijsen J A
Year:
1996
Bibliographic source:
Regulatory Toxicology & Pharmacology 27, 88–97 (1998); Article No. Rt971175

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Not specified.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
The temperature of the experimental animal room should have been 22°C ± 3° and the relative humidity 30-70 %.

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
air
Duration of exposure:
4 h
Concentrations:
The target concentration was 5000 mg/m3 or the highest vapor concentration obtained using a compressed air nebulizer.
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 000 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality.
Clinical signs:
other: During exposure decrease in breathing rates; wet head, nares and fur; piloerection; lachrymation; hunched appearance. Postexposure: Wet fur, sniffing, and slow movement; incidentallly apnea .
Body weight:
no effects reported.
Gross pathology:
Gross necropsy revealed pale lungs in incidental cases, and rusty brown lungs in two females exposed to benzyl lactate.

Any other information on results incl. tables

Acute Inhalation Toxicity ofLactate Esters in Rats:

Lactate

4 -h LC50 (mg/m3)

Observations

Methyl

>5030

 During exposure decrease in breathing rates and wet nares; Wet fur postexposure; Gross necropsy revealed 7 of 10 with grayish lungs; two lungs had irregular surfaces

Ethyl

>5400

 During exposure decrease in breathing rates; piloerection; wet nares; lachrymation; Gross necropsy revealed pale lungs with spots

Butyl

 >5140

 During exposure decrease in breathing rates and wet head and fur; No gross necropsy changes;

Isobutyl

>6160

 During exposure decrease in breathing rates; piloerection; hunched appearance; Postexposure: Apnea; No gross necropsy changes

Isoamyl

>4310

 During exposure decrease in breathing rates and wet head and fur; Wet fur, sniffing, and slow movement postexposure; Gross necropsy revealed 1 of 10 with pale lungs

Benzyl

>2420

 During exposure increase in breathing rates, irregular breathing patterns and wet nares and fur; Gross necropsy revealed rusty brown lungs in two females

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality was noted in the acute inhalation toxicity tests for the lactate esters at levels of > 2000 to > 5000 mg/m3. Clinical signs indicating acute irritant response are most likely due to the acute toxicity of the acid produced by rapid hydrolysis to lactic acid and the alcohol.