1-phenoxypropan-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted in compliance with GLP regulations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

phenoxypropanol

IUPAC Name:

phenoxypropanol

Constituent 2

Reference substance name:

1-phenoxypropan-2-ol

EC Number:

212-222-7

EC Name:

1-phenoxypropan-2-ol

Cas Number:

770-35-4

Molecular formula:

C9H12O2

IUPAC Name:

1-phenoxypropan-2-ol

Details on test material:

- Name of test material (as cited in study report): Protectol PP (CAS No 770-35-4)
- Physical state: liquid (solution)/colourless
- Composition of test material, percentage of components: 84.8% 1-phenoxy-propan-2-ol and 14.7% 2-phenoxy-propan-1-ol
- Lot/batch No.: P. 70-1840
- Stability under test conditions: verified by reanalysis
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

other: HanIbm : WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Woelferstrasse 4, CH-4414 Fuellinsdorf/ Switzerland
- Age at study initiation: 8 weeks for males, 11 weeks for females
- Weight at study initiation: 221 - 241 g for males, 200 - 214 g for females
- Diet: pelleted standard Kliba 343, batch no. 88/97 rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: community tap water from Itingen; ad libitum
- Acclimation period: 1 week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 24 hours before treatment, the backs of the animals were clipped with an electric clipper
- % coverage: 10 %
- Type of wrap if used: semi-occlusive dressing wrapped around the abdomen and fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was washed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.
- Time after start of exposure: 24 hours after the application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 1.84 ml corresponding to 2000 mg/kg (test substance density was approximately 1.086 g/ml)

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality / Viability: 4 times during test day 1 (of treatment and once daily for surviving animals during days 2-15; body weights: on test day 1 (pre-administration), 8 and 15 for surviving animals; clinical signs: each animal was examined for changes in appearance and behaviour (with special emphasis on the application area, except for the time when the semi-occlusive dressing was in place) 4 times during day 1, and once daily for surviving animals during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes; necropsies were performed by experienced prosectors. At the end of the observation period all animals were sacrificed by intraperitoneal injection of the equivalent to at least 320 mg sodium pentobarbitone/kg bw. The animals were examined macroscopically and all abnormalities recorded. Thereafter, they were discarded.
- Other examinations performed: clinical signs, body weight

Statistics:

no statistical analysis was used as no deaths occurred

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no deaths occurred at this dose level

Mortality:

no deaths occurred during the study.

Clinical signs:

other: neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period

Gross pathology:

no macroscopic findings were noted at necropsy.

Any other information on results incl. tables

Table 2: Body weight development

Treatment group	Mean body weight after (for survival animals)
	1 day		8 days		15 days
	Males	Females	Males	Females	Males	Females
Test group	233.0±9.9	205.0±5.6	262.5±13.9	207.8±4.9	290.6±15.8	212.3±7.0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of phenxoypropanol in rats is greater than 2000 mg/kg bw. Hence, no classification for acute dermal toxicity is required according to EU criteria.