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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-12-16 to 2015-02-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Experimental study according to guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassay Labor für biologische Analytik GmbH, 69120 Heidelberg
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-4-[(prop-2-yn-1-yloxy)methyl]benzene
EC Number:
813-130-5
Cas Number:
4039-86-5
Molecular formula:
C10H9ClO
IUPAC Name:
1-chloro-4-[(prop-2-yn-1-yloxy)methyl]benzene

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: male: approx. 8 weeks, female: approx. 12 weeks
- Weight at study initiation: Animals of comparable weight (± 20 % of the mean weight)
- Fasting period before study: no
- Housing: single, Makrolon cage, type III
- Diet: at libitum, VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, with bedding (H 15005-29; Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany))
- Water: ad libitum, tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 10
- 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: dorsal and dorsolateral parts of the trunk
- % coverage: About 40 cm² (corresponds to at least 10 % of the body surface)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 1.77 mL/kg bw
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Scoring: 30-60 min after removal, weekly and on last day of observation period
- Frequency of observations and weighing: Observations: several times on first day, afterwards at least once per day; weighing: shortly before application, weekly and on last day of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,
Statistics:
Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed. No local effects were observed.
Body weight:
Body weight of male animals increased within normal range.
One female showed a loss of body weight. Two females showed a stagnation of body weight in the first week but otherwise the increase was normal. One female showed a constant stagnation during the complete observation period. Due to the fact that stagnation or slight loss of body weight is commonly known for females dermally applied and the affected animals neither showed any clinical symptoms nor change in behavior these findings are considered to be unspecific.
Gross pathology:
No macroscopic pathologic abnormalities were observed.

Applicant's summary and conclusion