Registration Dossier

Administrative data

Description of key information

Justification for selection of skin irritation / corrosion endpoint:

WoE: No valid studies are available. All available data get a K4 since no original references are available only secondary references.  The results from animals studies show mild to moderate irritation. There are two studies available with human volunteers. 4% does not result in skin irritation the neat substance applied to the skin under occlusion 24-48h give slight to irritating reactions in 14 out of 212 volunteers. Based on the responses observed severe effects on the skin are not expected. The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2

Justification for selection of eye irritation endpoint:

WoE: No valid studies are available. All available data get a K4 since no original references are available only secondary references.

The results from animal studies show irritation to the eyes. The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2

Effects on skin irritation/corrosion:irritating

Effects on eye irritation:irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary references: WoE
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Remarks on result:
other: see Any Other Information

Skin corrosion/ irritation

WoE

No valid studies are available. All available data get a K4 since no original references are available only secondary references.

The results from animals studies show mild to moderate irritation. There are two studies available with human volunteers. 4% does not result in skin irritation the neat substance applied to the skin under occlusion 24-48h give slight to irritating reactions in 14 out of 212 volunteers. Based on the responses observed severe effects on the skin are not expected.The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2

 

Classification and Labeling

Irritant, Category 2

3 (strong capillary injection,this is described as moderate irritation)

 

Union carbide corp. unpublished data. Cited in[Clayton, G. D. and F. E. Clayton (eds.). Patty's Industrial Hygiene and Toxicology: Volume 2A, 2B, 2C: Toxicology. 3rd ed. New York: John Wiley Sons, 1981-1982., p. 4687]

In an acute dermal toxicity test three of four rabbits exhibited red and edematous skin and one exhibited hard and thick skin at 5 g/kg. Mild to moderate erythema and edema were seen at 2.5 and 1.25 g/kg

RIFM (Research Institute for Fragrance Materials, Inc.), 1977. Acute Toxicity Study in Rats, Rabbits and Guinea Pigs. RIFM Report No. 1695, April 08. RIFM, Woodcliff Lake, NJ, USA. Cited in:Scognamiglio J,Jones L,Letizia CS,Api AM.Fragrance material review on 2-phenyl-2-propanol.Food Chem Toxicol.2012 Sep;50 Suppl 2:S130-3.

Guinea Pig and Rabbit Skin: Daily application to the skin of rabbits and guinea pigs produced mild primary irritation.

HERCULES INC; Technical Data Bulletin for Di-Cup (Dicumyl Peroxide) Including Toxicity Data for A-Methylstyrene, One of its Decomposition Products; 00/00/00; EPA No. 86-870001667; Fiche No. OTS0515743

In a pretest for a human maximization study, 4% in petrolatum was applied under occlusion to the backs of 25 healthy adult volunteers for 48 h. No subject exhibited any irritation

RIFM (Research Institute for Fragrance Materials, Inc.), 1977. Report on Human Maximization Studies. RIFM Report No. 1702, June 06. RIFM, Woodcliff Lake, NJ, USA. Cited in:Scognamiglio J,Jones L,Letizia CS,Api AM.Fragrance material review on 2-phenyl-2-propanol.Food Chem Toxicol.2012 Sep;50 Suppl 2:S130-3.

14 of 212 human volunteers had slight to irritating reactions when patch tested with neat substance. Occluded patches were applied for 24–48 h on the back or on the flexor aspect of the forearm

Takenaka, T., Hasegawa, E., Takenaka, U., Saito, F., Odaka, T., 1968.Fundamental studies of safe compound perfumes for cosmetics. Part 1. The primary irritation of compound materials to the skin. ‘‘Preprint of Scientific Papers,’’ The Fifth

Congress of International Federation of Societies of Cosmetic Chemists, May 12-17, Tokyo, pp. 313–329. Cited in:Scognamiglio J,Jones L,Letizia CS,Api AM.Fragrance material review on 2-phenyl-2-propanol.Food Chem Toxicol.2012 Sep;50 Suppl 2:S130-3.

Interpretation of results:
Category 2 (irritant)
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
No valid studies are available. All available data get a K4 since no original references are available only secondary references.
The results from animals studies show mild to moderate irritation. There are two studies available with human volunteers. 4% does not result in skin irritation the neat substance applied to the skin under occlusion 24-48h give slight to irritating reactions in 14 out of 212 volunteers. Based on the responses observed severe effects on the skin are not expected. The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2
Executive summary:

No valid studies are available. All available data get a K4 since no original references are available only secondary references.

The results from animals studies show mild to moderate irritation. There are two studies available with human volunteers. 4% does not result in skin irritation the neat substance applied to the skin under occlusion 24-48h give slight to irritating reactions in 14 out of 212 volunteers. Based on the responses observed severe effects on the skin are not expected. The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
no data
GLP compliance:
no
Remarks on result:
other: see Any Other Information

Eye corrosion/ irritation

WoE

No valid studies are available. All available data get a K4 since no original references are available only secondary references.

The results from animal studies show irritation to the eyes.The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2

 

Classification and Labeling

Irritant, Category 2

5 (Scale of 1 - 10; 1 = no observed reaction; 10 = most severe)

Union carbide corp. unpublished data. Cited in[Clayton, G. D. and F. E. Clayton (eds.). Patty's Industrial Hygiene and Toxicology: Volume 2A, 2B, 2C: Toxicology. 3rd ed. New York: John Wiley Sons, 1981-1982., p. 4687]

Application of 0.1 ml to the eyes of rabbits and 0.05 ml to the eyes of guinea pigs daily for 15 days produced some irritation with erythema. There was complete recoverywithin 7-14 days, with no permanent corneal damage.

HERCULES INC; Technical Data Bulletin for Di-Cup (Dicumyl Peroxide) Including Toxicity Data for A-Methylstyrene, One of its Decomposition Products; 00/00/00; EPA No. 86-870001667; Fiche No. OTS0515743

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
No valid studies are available. All available data get a K4 since no original references are available only secondary references.
The results from animal studies show irritation to the eyes. The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2
Executive summary:

No valid studies are available. All available data get a K4 since no original references are available only secondary references.

The results from animal studies show irritation to the eyes. The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

Skin: No valid studies are available. All available data get a K4 since no original references are available only secondary references. The results from animals studies show mild to moderate irritation. There are two studies available with human volunteers. 4% does not result in skin irritation the neat substance applied to the skin under occlusion 24-48h give slight to irritating reactions in 14 out of 212 volunteers. Based on the responses observed severe effects on the skin are not expected. The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2

Eye: No valid studies are available. All available data get a K4 since no original references are available only secondary references. The results from animal studies show irritation to the eyes. The lack of individual scores and the use of a non-standard technique preclude classification on the basis of EU or GHS criteria. A precautionary approach is chosen and the substance is classified: Irritant, Category 2