Bis(2-ethylhexan-1-olato)bis(pentane-2,4-dionato-O,O')titanium

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

2-ethylhexanol is the main hydrolysis of the target substance, properties of which are used for read-across.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Developmental toxicology of 1-pentanol, 1-hexanol, and 2-ethyl-1-hexanol by inhalation to rats

Author:

Nelson BK, Brightwell WS, Khan A, Krieg EF Jr., and Hoberman AM

Year:

1989

Bibliographic source:

J. Am. Coll. Toxicol. 8(2): 405- 410.

Reference 2

Reference Type:

publication

Title:

Developmental toxicity of industrial alcohols: a summary of 13 alcohols administered by inhalation to rats.

Author:

Nelson BK, Brightwell WS, and Krieg EF Jr.

Year:

1990

Bibliographic source:

Toxicology and Industrial Health, 6: 373-387.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

yes

Remarks:

low number of animals: 15 females instead of 25

Principles of method if other than guideline:

low number of animals: 15 females instead of 25

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexan-1-ol

EC Number:

203-234-3

EC Name:

2-ethylhexan-1-ol

Cas Number:

104-76-7

Molecular formula:

C8H18O

IUPAC Name:

2-ethylhexan-1-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure (if applicable):

whole body

Vehicle:

air

Details on exposure:

Exposure apparatus: 0.5 m³ whole body exposure chamber (hinners-type)
Method of holding animals in test chamber: animals were caged

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

gestation day 1 - 19

Frequency of treatment:

daily, 7 hr/day

Duration of test:

19 days

Doses / concentrations

Dose / conc.:

850 mg/m³ air (analytical)

No. of animals per sex per dose:

15 females

Control animals:

yes, concurrent vehicle

Details on study design:

Dose selection rationale: the highest achievable concentration was used (850 mg/m³) which could be generated as a vapor while maintaining the chamber temperature <26°C. As no maternal toxicity was noted, there was no need to test lower concentrations.

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:

no effects observed

Maternal developmental toxicity

Number of abortions:

no effects observed

Effect levels (maternal animals)

1

Key result

Dose descriptor:

NOAEC

Effect level:

ca. 850 mg/m³ air

Based on:

test mat.

Basis for effect level:

other: maternal toxicity

2

Key result

Dose descriptor:

NOAEC

Effect level:

ca. 850 mg/m³ air

Based on:

test mat.

Basis for effect level:

other: developmental toxicity

Maternal abnormalities

Key result

Abnormalities:

no effects observed

Results (fetuses)

Fetal body weight changes:

no effects observed

Effect levels (fetuses)

Key result

Dose descriptor:

NOAEC

Effect level:

ca. 850 mg/m³ air

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

no effects observed

Overall developmental toxicity

Key result

Developmental effects observed:

no

Applicant's summary and conclusion

Conclusions:

No signs of maternal and fetal toxicity were noted in this inhalation study, where the maximum vapour concentration was used which does not lead to formation of aerosol.

Executive summary:

As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.