3-(2,2-dimethyl-3-hydroxypropyl)toluene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2002-12-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

3-(2,2-dimethyl-3-hydroxypropyl)toluene

EC Number:

403-140-4

EC Name:

3-(2,2-dimethyl-3-hydroxypropyl)toluene

Cas Number:

103694-68-4

Molecular formula:

C12H18O

IUPAC Name:

2,2-dimethyl-3-(3-methylphenyl)propan-1-ol

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Microbiological status of animals, when known: not specified
- Age at study initiation: young adults
- Weight at study initiation: not specified
- Housing: 4 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: none

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: 30 - 70%
- Air changes: 15 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

3, 10, and 30 % (w/v)

No. of animals per dose:

four

Details on study design:

PRE-SCREEN TESTS:
- Irritation: not observed
- Systemic toxicity: not observed

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

the results with the positive control confirmed the validity of the study

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

1.47

Test group / Remarks:

3 %

Results 2

Key result

Parameter:

SI

Value:

1.3

Test group / Remarks:

10 %

Results 3

Key result

Parameter:

SI

Value:

3.07

Test group / Remarks:

30 %

Cellular proliferation data / Observations:

CLINICAL OBSERVATIONS: no signs of toxicity were observed in the course of the study

Any other information on results incl. tables

Table 1 Summary results

 

Concentration (% w/v) in acetone/olive oil 4:1	cpm (counts per minute)	cpm/Node	Test Control ratio (SI)
Vehicle	1516	1.90	na
3	2240	2.80	1.47
10	1974	2.47	1.30
30	4662	5.83	3.07

 

na = Not applicable

Applicant's summary and conclusion

Interpretation of results:

other: skin sensitisation potential is indicated based on the results of this study, however an overall conclusion is made based on the weight of evidence as discussed in the endpoint summary.

Conclusions:

Based on the results of this OECD 429 compliant study, the test item indicates a skin sensitising potential.

Executive summary:

The test item was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The assay determines the level of T lymphocyte proliferation in the lymph nodes draining the site of chemical application, by rneasuring the amount of radiolabelled thymidine incorporated into the dividing cells. The test substance was applied as 3%, 10% or 30% w/v preparations in acetone in olive oil (4:1). The test substance was shown to have the capacity to cause skin sensitisation when applied as a 30% w/v preparation in acetone in olive oil. In a positive control study, hexylcinnamaldehyde was shown to have the capacity to cause skin sensitisation when applied as 3% or 10% w/v preparations in acetone, confirming the validity of the protocol used for this study. The test item indicates a skin sensitising potential under the conditions of the test.