Dimethyl phthalate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is not assignable. Only secondary literature and only short table available. However, reliable key studies with restrictions (non-GLP studies) are available for the first, the oral route via (gavage) and second, the dermal route. These routes are likely to be of more human relevance than the inhalative route due to the low vapour pressure of the substance.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Inhalation toxicity tests-Environmental assessment & toxicology Monsanto company

Author:

Levinskas GJ.

Year:

1973

Bibliographic source:

Techn. Pap. Reg. Tech. Conf. p. 95-100. Soc . Plastics Engineers Inc.

Reference 2

Reference Type:

secondary source

Title:

Toxicity Profile, Dimethylphthalate, November 1987

Author:

BIBRA

Year:

1987

Bibliographic source:

BIBRA

Reference 3

Reference Type:

secondary source

Title:

No information

Author:

ECB-IUCLID

Year:

2000

Bibliographic source:

European Chemicals Bureau, 11-FEB-2000

Materials and methods

Principles of method if other than guideline:

Method: other: Industrial acute inhalation toxicity test, groups of animals were exposed for 4h to graded air concentrations of the test substance and observed 14 days thereafter

GLP compliance:

no

Test type:

other: inhalation toxicity test, no further details

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl phthalate

EC Number:

205-011-6

EC Name:

Dimethyl phthalate

Cas Number:

131-11-3

Molecular formula:

C10H10O4

IUPAC Name:

1,2-dimethyl benzene-1,2-dicarboxylate

Test material form:

liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

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
- Method of conditioning air: air was bubbled through the material and led directly into a chamber containing the animals, this results in an air stream near saturation; saturated vapor exposure

Duration of exposure:

6 h

Concentrations:

Only stated: saturated atmosphere (limited reporting); the calculated saturated vapour pressure is 10.4mg/L (based on vapour pressure 0.0013hPa at 20°C and the molecular weight 194.2g/mol) - an aerosol of the test substance might have been generated.

No. of animals per sex per dose:

no details reported

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LC50

Effect level:

> 10.4 mg/L air (nominal)

Exp. duration:

6 h

Remarks on result:

other: no concentration/dose reported, only saturated vapor; calculation of concentration based on the molecular weight of the test substance (194.2g/mol); an aerosol might have been generated

Mortality:

There were no deaths when an unspecified number of rats were exposed to the saturated vapour for 6 h within observation period of 14 days.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 for acute inhalation toxicity is greater than 10.4 mg/L/6h at saturated vapor.

Executive summary:

The study is not assignable, only published in a short table (secondary literature) and reporting is very limited (non-GLP study). Acute inhalation toxicity (6h saturated vapor) was tested in rats, no mortalities were observed within 14 days. However, an aerosol might have been generated.

The LD50 for acute inhalation toxicity is greater than 10.4 mg/L/6h at saturated vapor.