Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 Feb - 05 Mar 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Alpha-Chloro C-6 Monomer
- Physical state: colourless liquid
- Lot/batch No.: C61204
- Expiration date of the lot/batch: 31 Aug 2004
- Storage condition of test material: In refrigerator in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: single housing
- Diet: Standard laboratory diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany), approx. 100 g per day. Hay was provided three times per week.
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1-21.0 (actual temperature)
- Humidity (%): 39-61 (actual humidity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2 cmx3 cm
- Type of wrap if used: metalline patch on micropore tape, wrapped around the abdomen and secured with coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean after 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean after 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean after 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean after 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Slight oedema (grade 1) were observed in all 3 animals 1 hour after exposure and were fully reversible within 24 h.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No staining of the treated skin by the test substance was observed and no test substance remnants were seen.

Any other information on results incl. tables

Table 1: Individual results of the skin irritation study.

Rabbit No.

1

2

3

Observation time

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

2

1

2

1

2

1

24 h

2

0

1

0

1

0

48 h

1

0

0

0

1

0

72 h

0

0

0

0

0

0

Mean value

1.0

0.0

0.3

0.0

0.7

0.0

24 + 48 + 72 h

Table 2: Age and body weight of the animals.

Rabbit No.

1

2

3

Age at start (weeks)

10-12

7-9

7-9

Body weight (gram)

 

 

 

prior to application

2484

1545

1771

at termination

2605

1650

1835

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified