Registration Dossier

Administrative data

Description of key information

Oral:  WoE: The available LD50s range from ± 1000 – 3000 mg/kg bw.

Inhalation: No valid studies are available. The available study gets a K4 since no original references are available only secondary references. No LD50 is available, no LD50 available, data is not sufficient for C&L purposes.

This substance is a transported isolated intermediate and therefore no additional testing is warranted.

Dermal: No valid studies are available. The available study gets a K4 since no original references are available only secondary references. The available LD50 is 4300 mg/kg bw. Since only one secondary reference is available the data is not sufficient for C&L purposes.

This substance is a transported isolated intermediate and therefore no additional testing is warranted.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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

Acute oral

 

 

WoE

Since no original references are available only secondary references all available data is K4.

The available LD50s range from ± 1000 – 3000 mg/kg bw. Since most of the values are < 2000 mg/kg the substance is classified for acute oral toxicity: Acute oral Category 4.

 

Classification and Labeling

Acute oral Category 4.

LD50 rat: 1300 mg/kg (1000-1700 mg/kg)

 

 

The acute oral LD50 for 2-phenyl-2-propanol in rats was reported to be 1.3 g/kg (1.0–1.7 g/kg). Rats (10/dose) were dosed by orally at doses of 0.6, 0.85, 1.22, 1.73, 2.47, and 5.0 g/kg. Mortalities were 0, 3, 4, 6, 10, and 10 with increasing does; all animals died within 2 days of dosing. Clinical observations included lethargy, ataxia, loss of righting reflex, and coma. Necropsy observations included oral and nasal excretions, redness, yellowing and bloating in the intestines, red areas in stomach, dark lungs, and dark and/or mottled kidneys,

Moreno. O. M. (1977). Report to RIFM. 7 October. Cited in:Food and Chemical Toxicology. Vol. 20, Pg. 675, 1982

 

RIFM (Research Institute for Fragrance Materials, Inc.), 1977a. 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.

 

LD 50 rat: 1.07 ml/kg (± 1 g/m3, ± 1000 mg/kg)

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

The oral LD50 in the rat ranged from 1400 to 3000 mg/kg. The oralLDin the rat of a mixture of 75% of the substance and 25% acetophenone was found to be 2000 mg/kg.

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

LD50 rat: 2250 mg/kg

With clinical signs of toxicity similar to those of narcotics

Bukhalovskii, A. A. & Shugaev, B. B. (1976). Toksichnost i gigienicheskoe normirovanie izoforona, digidroizoforona

i dimetilfenilkarbinola.Promyshlennost Sillleticheskogo Kauchuka1976 (2), 4. Cited in:Food and Chemical Toxicology. Vol. 20, Pg. 675, 1982

LD50 mice: 1950 mg/kg

With clinical signs of toxicity similar to those of narcotics

Bukhalovskii, A. A. & Shugaev, B. B. (1976). Toksichnost i gigienicheskoe normirovanie izoforona, digidroizoforona

i dimetilfenilkarbinola.Promyshlennost Sillleticheskogo Kauchuka1976 (2), 4. Cited in:Food and Chemical Toxicology. Vol. 20, Pg. 675, 1982

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Since no original references are available only secondary references all available data is K4. The available LD50s range from ± 1000 – 3000 mg/kg bw. Since most of the values are < 2000 mg/kg the substance is classified for acute oral toxicity: Acute oral Category 4.
Executive summary:

Since no original references are available only secondary references all available data is K4. The available LD50s range from ± 1000 – 3000 mg/kg bw. Since most of the values are < 2000 mg/kg the substance is classified for acute oral toxicity: Acute oral Category 4.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of acute toxicity – oral endpoint

Since no original references are available only secondary references all available data is K4.

The available LD50s range from ± 1000 – 3000 mg/kg bw. Since most of the values are < 2000 mg/kg the substance is classified for acute oral toxicity: Acute oral Category 4.

Justification for classification or non-classification

Acute oral: Since no original references are available only secondary references all available data is K4.

The available LD50s range from ± 1000 – 3000 mg/kg bw. Since most of the values are < 2000 mg/kg the substance is classified for acute oral toxicity: Acute oral Category 4.

Acute inhalation: No LD50 available, data is not sufficient for C&L purposes.

Acute dermal: Since only one secondary reference is available the data is not sufficient for C&L purposes.