2,2-dimethyl-3-phenylpropanol

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-08-31 to 1981-10-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Equivalent to OECD guideline 406, no GLP study, unclear if highest non irritating dose was used. Only 20 % mixture in peanut oil was tested.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

no

Type of study:

Buehler test

Species:

guinea pig

Strain:

Pirbright-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchtstierzucht, Hagemann GmbH & Co. KG, Hamelner Straße 3, 4923 Exertal
- Weight at study initiation: 250 g (mean weight)
- Housing: Macrolon cages III, height: 14 cm, width: 25 cm, length: 42 cm
- Diet: Ssniff-G, pellets
- Water: ad libitum, tap water
- Acclimation period: ca 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-2
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12, light from 7 am to 7 pm

Route:

epicutaneous, semiocclusive

Vehicle:

peanut oil

Concentration / amount:

0.5 mL

Route:

epicutaneous, semiocclusive

Vehicle:

peanut oil

Concentration / amount:

0.5 mL

No. of animals per dose:

20 females test group
10 females control group

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test group: 20 test animals were treated once a week for the duration time of 3 weeks on the clipped left side with the test substance.
- Control group: 10 animals were treated only with the vehicle in a similar manner to that used for the treated group.
- Site: Clipped left side
- Frequency of applications: every week
- Duration: 3 weeks
- Concentrations: 0.5 mL in a 20 % mixture in peanut oil.

B. CHALLENGE EXPOSURE (14 days after the last induction exposure)
- No. of exposures: 3
- Exposure period: 6 hours
- Test group/ Control group: Both groups are treated with the test substance on the right side of the animals.
- Site: Right side
- Concentrations: 0.5 mL in a 20 % mixture in peanut oil.
- Evaluation (hr after challenge): Right side was depilated after 24 hours, evaluation after 2 hours, 24 and 48 hours

Positive control substance(s):

no

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 mL

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 mL

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.5 mL

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0.5 mL

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 10.0.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The skin sensitizing potential of the test item was tested in the Buehler Test, using 20 % of the test substance in peanut oil. No sensitizing potential was found under the test conditions.

Executive summary:

The skin sensitizing potential of the test item was tested in the Buehler Test, using 20 % of the test substance in peanut oil. A sensitization study was conducted using white Pirbright guinea pigs weighing approx. 250 gm at the start of the study. Animals were housed 2/cage in macrolon plastic cages. Bedding was from pure spuce-, fir- or pine-wood, dried and disdusted. Fluorescent lighting was on 12 hr daily, temperature was 21 C, and relative humidity, 45 to 55%. Food and water was provided ad libitum. After an acclimatization period of 7 days, animals were divided into two groups of 20 female animals (test group) and 10 female animals (control group). Prior to treatment, the left shoulder of each animal was clipped with a small animal clipper (about 8 x 5 cm). 0.5 mL of the test substance was applied undiluted to a 2 x 2 cm gauze pad. The patches were placed on the clipped left shoulder of each animal of the test group and secured with a wrapping of Elastoplast. Then the animals were immobilized in restrainers for 6 hours. After that time the patches were taken off. The procedure was repeated at the same side once weekly during the next two weeks for a total of three 6 hr exposures. After the last induction exposure, the animals were left untreated for 2 weeks before primary challenge. The animals previously exposed during the induction period as well as the previously untreated control animals were treated following the same patching procedure as for induction but the patches were applied to the freshly clipped right side that has not been treated before. 24 hours after the primary challenge all animals were depilated on the right side. The test sites were graded 6, 24 and 48 hours after the depilation by comparing the treated test animals with the animals of the control group. Any signs of erythema and other lesions were recorded. No skin sensitizing potential was observed during the study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitizing potential of the test item was tested in a Buehler Test, using 20 % of the test substance in peanut oil. This test concentration was probably close to the irritation threshold. The substance has proven to be skin irritating in a tested purity of 99.6 %. The sensitization study was conducted using white Pirbright guinea pigs weighing approx. 250 g at the start of the study. After an acclimatization period of 7 days, animals were divided into two groups of 20 female animals (test group) and 10 female animals (control group). Prior to treatment, the left shoulder of each animal was clipped with a small animal clipper (about 8 x 5 cm). 0.5 mL of the test substance was applied undiluted to a 2 x 2 cm gauze pad. After the last induction exposure, the animals were left untreated for 2 weeks before primary challenge. 24 hours after the primary challenge all animals were depilated on the right side. The test sites were graded 6, 24 and 48 hours after the depilation by comparing the treated test animals with the animals of the control group. Any signs of erythema and other lesions were recorded. No skin sensitizing potential was observed during the study sensitizing.

In addition, other substances (2-phenylethanol (CAS 60-12-8), 3-(2,2-dimethyl-3-hydroxypropyl)toluene (CAS 103694-68-4), Methyl-1-phenyl-propan-2ol (CAS 100-86-7), 3-Phenyl-1-propanol (CAS 122 -97 -4)) belonging to the same group of phenyl alcohols have proven to be non-skin sensitizer. All the substances contain the following functional groups: a primary alcohol group adjacent to carbon chains with only small differences in chain length and an aromatic group. Because of comparable structural characteristics and identical functional groups of the target and the source substances it can be presumed that their toxicological properties are similar as shown below.

2-phenylethanol (CAS 60-12-8) was tested in a study according to OECD guideline 429. No skin sensitizing effects were determined (ECHA disseminated dossier). The substance was tested in a purity of 99.9 %. 3-(2,2-dimethyl-3-hydroxypropyl)toluene (CAS 103694-68-4) was tested in an OECD guideline 406 study (maximization test) in guinea pigs. The test substance was not classified for skin sensitisation (ECHA disseminated dossier). Methyl-1-phenyl-propan-2ol (CAS 100-86-7) was tested undiluted in an open epicutaneous test with guinea pigs. No skin sensitizing effects were determined. Same results were observed in another open epicutaneous test with guinea pigs testing the substance in induction concentrations of 100%, 30%, 10%, 1% and 0.3%. 3-Phenyl-1-propanol (CAS 122-97-4) showed also no skin sensitizing effects based on OECD guideline in-vitro skin sensitization data and human patch data.

Conclusion: No skin sensitizing potential was determined in all substances. The performed studies were reliable and standardized test systems. They can be used to predict skin sensitization in an adequate and realistic way. These results are in-line with the result of the target substance observing no skin sensitizing potential.

Migrated from Short description of key information:
The skin sensitising potential of the test item was tested in a Buehler test. No skin sensitizing effects were observed in the study.

Justification for selection of skin sensitisation endpoint:
No guideline and no GLP study, unclear if highest non irritating dose was used, probably technichal pure quality was tested

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008.