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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: Experimental study conducted on a structural similar substance.
Adequacy of study:
key study
Study period:
01/02/2012-15/02/2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report):Brominated Epoxy having Epoxy Equivalent of 400gr.eq
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: pale yellow solid
- Analytical purity:not supplied
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: B21E-86
- Expiration date of the lot/batch: 30/05/2014
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: room temperature in the dark
- Other:

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Harlan Laboratories UK Ltd., Oxon, UK
- 5 males and 5 females
- Age at study initiation: 8-12 weeks
- Weight at study initiation: at least 200g
- Fasting period before study:
- Housing:In suspended solid-floor polypropylene cages furnished with woodflakes. Housed individually during the 24-hour exposure period and in groups of five by sex for the remainder of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12hours dark/12 hours light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
DMSO
Details on dermal exposure:
TEST SITE
- Area of exposure:back and flanks
- % coverage:10% of the total body surface area, using a graduated syringe.
- Type of wrap if used: surgical gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done):with cotton wool moistened with DMSO
- Time after start of exposure:24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- Constant volume or concentration used: yes
-The test material was moistened with the vehicle-DMSO and then was applied evenly on the skin.



Duration of exposure:
24h
Doses:
2000mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, signs of toxicity, irritation

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
95% CL:
>
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
no deaths
Clinical signs:
no signs of systemic toxicity
Body weight:
Animals showed expected gains in bodyweight over the study period except for one female which showed bodyweight loss during the first week but expected gain in bodyweight during the second week.
Gross pathology:
No abnormalities
Other findings:
Dermal reactions:
Very slight erythema was noted at the test sites of nine animals. Small superficial scattered scabs and/or hardened light brown coloured scabs were also notated at the test sites of eight animals. Haemorrhage of dermal capillaries and/or glossy skin was noted at the test sites of eight animals. Scab lifting to reveal glossy skin was noted at the test site of one animal. There were no signs of dermal irritation noted at the test site of one male.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bw
Executive summary:

Introduction: The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following: OECD 402, B3 EC, EPA OPPTS 870.1200

Method: A group of ten animals (five males and 5 females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000mg/kg bodyweight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results:

Mortality: there were no deaths

Clinical observations: no signs of systemic toxicity

Dermal irritation: Signs of dermal irritation noted were very slight erythema, haemmorrhage of dermal cappilaries, small superficail scattered scabs, hardened light brown coloured scabs, glossy skin and scab lifting to reveal glossy skin. There were no signs of dermal irritation noted at the test site of one male.

Bodyweight: Animals showed expected gains in bodyweight over the study period, except for one female which showed bodyweight loss during the first week but expected gain in bodyweight during the second week.

Necropsy: No abnormalities were noted

Conlusion: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bw