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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

The target substance is hydrolytically unstable with hydrolysis half-life estimated to be less than 30 minutes, and with hydrolysis products being identified to be 2-ethylhexanol and acetylacetone. Because of the rapid hydrolysis, the influence of the target substance is related to its hydrolysis products.
2-ethylhexanol is the major hydrolysis product. It's toxicity property is used for read-across.

Data source

Reference

Reference Type:

publication

Title:

2-Ethylhexanol

Author:

BG-Chemie

Year:

1995

Bibliographic source:

Toxikologische Bewertungen, Programm zur Verhütung von Gesundheitsschädigungen durch Arbeitsstoffe

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Assessment of human data. Review of patch test data on humans following exposure of 2-ethylhexanol

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

Existing study conducted on human and adopted by peer-revieed journal.

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

In vivo test system

Test animals

Species:

other: Human

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Concentration / amount:

4%, 1mL

Day(s)/duration:

28 hours

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Concentration / amount:

4%, 0.4ml

Day(s)/duration:

48 hours

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

29

Details on study design:

Skin areas were pretreated with 5% sodium lauryl sulphate for 24 h. The induction was then performed four times for 28 h each with a cotton cloth soaked in a 4% solution of EH in paraffin oil. The challenge was performed with 4% EH for 48 h.

Positive control substance(s):

not specified

Results and discussion

Positive control results:

Not specified.

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

4%

No. with + reactions:

0

Total no. in group:

29

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

96

Group:

test chemical

Dose level:

4%

No. with + reactions:

0

Total no. in group:

29

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Skin sensitisation was not observed in a study on 29 volunteers using patch test method. 2-ethylhexanol was concluded non-sensitsing.

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.