Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters

Acute Toxicity: inhalation

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

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl, Ethyl, Propyl, Isopropyl, Butyl, Isoamyl, 2-Ethylhexyl, Isodecyl and Benzyl lactate

IUPAC Name:

Methyl, Ethyl, Propyl, Isopropyl, Butyl, Isoamyl, 2-Ethylhexyl, Isodecyl and Benzyl lactate

Details on test material:

Not specified.

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system 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.