2-phenoxyethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-phenoxyethanol

EC Number:

204-589-7

EC Name:

2-phenoxyethanol

Cas Number:

122-99-6

Molecular formula:

C8H10O2

IUPAC Name:

2-phenoxyethan-1-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ORIENT BIO Inc. (322, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea)
- Age at administration: 9 - 10 weeks
- Weight at administration: 221 - 247 g (preliminary test); 231 - 233 g (main test)
- Fasting period before study:
- Housing: single animals in Polycarbonate cage(W 420 x L 270 x H 180 mm)
- Diet: rodent diet 1314 IRR[Altromin Spezialfutter GmbH & Co. KG(Im Seelenkamp 20, D-32791 Lage Postfach 11 20, D-32770 Lage)].
- Water (e.g. ad libitum): Public tap water were filtered and sterilized by ultraviolet light
- Acclimation period: more than 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 - 21.9
- Humidity (%): 46.3 - 55.4
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 11 May 2021 To 04 June 2021

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4 × 4 cm^2
- % coverage: approx. 10%
- Type of wrap if used: held in contact with the skin with a porous gauze dressing, non-irritating tape (Tegarderm, 3M) and adhesive band (Coban, 3M)

REMOVAL OF TEST SUBSTANCE
- Washing: gently wahsed with sterile distilled water
- Time after start of exposure: after 24h of application.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): based on the body weight measured right before administration

Duration of exposure:

24 hours

Doses:

Preliminary test: 200, 1000, 2000 mg/kg bw
Main test: 2000 mg/kg bw

No. of animals per sex per dose:

Preliminary test: 1 animal/dose
Main test: 2 animals/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: 0.5, 1, 2, 3, 4, 5 and 6 hours after administration and then once each day for 14 days.
Body weight: Day 0 (just before administration) and on Days 7 and 14 (before necropsy).
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

No mortality and no clinical signs were observed in the animal treated with 200, 1000, 2000 mg/kg bw. Body weights developed normally an no remarkable necropsy findings were observed at any dose group tested.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality observed.
No. of dead animals/ total animals (preliminary + main test):
0/1 at 200 mg/kg bw
0/1 at 1000 mg/kg bw
0/3 at 2000 mg/kg bw

Gross pathology:

No abnormal findings were observed during necrospy

Any other information on results incl. tables

- No dead animals were observed during the study period.
- No clinical signs related to test substance administration were observed.
- No abnormal body weight changes were observed.)
- No abnormal findings were observed during necrospy.

Applicant's summary and conclusion

Executive summary:

The purpose of this study was to assess the toxicity of the test substance, 2-Phenoxyethanol following a single dermal administration to Sprague Dawley rats.
The dose levels of preliminary test were set at 200 mg/kg bw (Step 1), 1000 mg/kg bw (Step 2) and 2000 mg/kg bw (Step 3), and one female animal were used per dose group. The dose levels of the main test was set at 2000 mg/kg bw, based on the preliminary test findings and two female animals were used. The test substance was applied undiluted and uniformly over a clipped area (approx. 10% of total body surface) of the dorsal/flank area under occlusive conditions. All animals were monitored for clinical signs and body weight changes during the 14 days observation period after administration. They were subjected to gross necropsy at the end of the observation period.
No test substance-related dead animals and clinical signs were observed during the study period. No abnormal body weight changes related to the test substance administration were observed. At necropsy, there were no lesions caused by administration of the test substance.

Based on the results of the acute dermal toxicity study in Sprague Dawley rats, the test substance was virtually non-toxic after single dermal administration and the LD50 was set at > 2000 mg/kg bw.