Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Acute Toxicity:

Based upon the results of the acute oral acute oral toxicity study in rats, the calculated acute oral LD50 for male and female treated with Phenethyl alcohol was determined to be 1609.3 mg/kg with confidence limits of 1399.6 to 1850.4 mg/kg. The calculated acute oral LD50 for males was determined to be 1692.6 mg/kg with 95% confidence limits of 1433.3 to 1998.9 mg/kg.

According to GHS an oral LD50 of < 300 to ≤ 2 000 mg/kg, constitutes an acute toxicity hazard category of 4. H302 -Harmful if swallowed.

Skin Irritation:

Test on Guinea pigs and rabbits on the read-acoss subtance Phenylethyl alcohol led to the conclusion that the substance is a moderate irritant, however the test on miniature swine did not show any irritant effects. This is not sufficient for C & L purposes as the total score was the average of the reddening rate ( erythema, 72 h reading), the dilating rate, the swelling rate, and the bluing rate of 6 animals in a group. Only two parameters out of these can be used for C & L purposes therefore the subtance cannot be classified as a moderate irritant.

A patch test on a panel of 50 male adults on the read-acoss subtance Phenylethyl alcohol (in 32% actone) was found to be negative for skin irritation. Since no skin irritation effect were seen in miniature swine and in particular the humans patch test the substance Phenylethyl alcohol was concluded as not an skin irritant overall.

Eye Irritation:

The eye irritation study conducted to OECD Guideline 405 (Acute Eye Irritation / Corrosion) on the read-across substance phenylacetic acid has been concluded as a GHS category 1 eye irritation. It was found that in at least 2 animal's effects on the cornea were not fully reversed fully within an observation period of 21 days, thus leading to the justification of the GHS categoty 1 classification. According to DSD - Xi: R41; Risk of serious damage to eyes.

Skin Sensitisation:

A weight of evidence constructed to assess the risk of sensitisation from the read-across substances, phenylethyl alcohol and phenyl ethanol led to the conclusion the subtance is not a sensitiser.

Genetic Toxicity:

Genotoxicity and cytotoxicity of phenylacetic acid was determined by Heck JD (1990) in a battery of in vitro tests on food flavouring ingredients. A salmonella mutagenesis assay (comparable to an Ames test), an unscheduled DNA synthesis assay and a mouse lymphoma forward mutation assay all proved negative in the presence of phenylacetic acid.

Developmental toxicity/ teratogenecity:

There was no evidence of maternal or fetal toxicity at any dose level after dietary administration. Maternal toxicity -NOAEL = 5000 ppm(nominal). Developmental toxicity -NOAEL = 5000 ppm (nominal)