Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In vivo skin irritatation study is available and therefore was used in the submission.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29/06/1999-02/07/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Brominated epoxy having epoxy equivalent of 400gr/eq
- Physical state:solid
- Lot/batch No.:B21E-86
- Expiration date of the lot/batch: 30/05/2014
- Storage condition of test material: under ambient conditions in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederland, The Netherlands
- Age at study initiation:at least 6 weeks
- Weight at study initiation:less than 3.5kg
- Housing:Individually housed in labelled cages with perforated floors (Scanbur Denmark) and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): approx. 100g per day
- Water (e.g. ad libitum):ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21°C
- Humidity (%):50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light, 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: test substance was mistened with water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 of one sex
Details on study design:
TEST SITE
- Area of exposure:150cm²
- Type of wrap if used: a Metallin patch (2x3 cm) was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic badage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: four hours

SCORING SYSTEM:
EYRTHEMA AND ESCHAR FORMATION:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness):4

OEDEMA FORMATION:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1mm): 3
Severe oedema (raised more than 1mm and extending beyond area of exposure): 4







Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
no skin irritation was caused by 4 hours of exposure to F-2200HM
Other effects:
no other effects were reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commision Directive 93/21/EEC). F-2200HM does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

Primary skin irritation/corrosion study with F-2200HM in the rabbit (4 -hour semi-occlusive application).

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.4: 'Acute Toxicity. Skin irritation' and OECD No. 404, 'Acute Dermal Irritation/Corrosion'.

Three rabbits were exposed to 0.5 gram of F-2200HM, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

No skin irriation was caused by 4 hours of exposure to F-2200HM.

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), F-2200HM does not have to be classified and has no obligatory labelling requirement for skin irritation.