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Acute Toxicity: dermal

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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

Constituent 1
Reference substance name:
phenoxypropanol
IUPAC Name:
phenoxypropanol
Constituent 2
Chemical structure
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:
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
Body weight:
the body weight of the animals was within the range of physiological variability known for rats of this strain and age (see Table 1).
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.

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