Diundecyl phthalate, branched and linear

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1971

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Older study conducted prior to the introduction of GLP and OECD test guidelines. Standard methods used but details of methods and results not available. For read-across justification see Section 13.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rats given single doses of DUP of up to at least 1.8 mg/l as a vapour. Animals observed for signs of toxicity for 10 days. Animals weighed and subject to necropsy and macroscopic examination.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diundecyl phthalate

EC Number:

222-884-9

EC Name:

Diundecyl phthalate

Cas Number:

3648-20-2

Molecular formula:

C30H50O4

IUPAC Name:

diundecyl benzene-1,2-dicarboxylate

Details on test material:

No data

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

not specified

Details on inhalation exposure:

6 h exposure at room temperature & 300 degrees F

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

6 h

Concentrations:

Up to at least 1.8 mg/l

No. of animals per sex per dose:

4

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (or other?): 10d
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes/no: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No

Statistics:

No data

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LC50

Effect level:

> 1.8 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: Room temperature; No 95% confidence limits calculable

Effect levels 2

Sex:

not specified

Dose descriptor:

LC50

Effect level:

> 1.8 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: T degrees F = 300; 95% CL not calculable

Mortality:

None at room temperature or 300 degrees F

Clinical signs:

other: No toxic effects at room temperature. At 300 degrees F slight lethargy

Body weight:

None at room temperature or 300 degrees F

Gross pathology:

None at room temperature or 300 degrees F

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Six hours exposure to a saturated vapour concentration of 1.8 mg/L, resulted in no mortality.

Executive summary:

Six hours exposure to a saturated vapour concentration of 1.8 mg/L, resulted in no mortality. The vapour concentration tested is considered to represent the highest achievable