Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD) (test substance purity not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted 29 Dec, 1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Epicol G24 G2, C12/14alpha-Epoxid, ringgeöffnet mit Glykol, SAT970397
- Physical state: colorless, transparent fluid
- Analytical purity: not specified
- Lot/batch No.: 10017020
- Expiration date of the lot/batch: 1997-01-20
- Storage condition of test material: room temperature, darkness

Test animals

Species:
rabbit
Strain:
other: SPF albino, Mol:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Lille Skensved, Danmark
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: single housing in PPO cages
- Diet: pelleted complete rabbit diet, altromin 2123, ad libitum
- Water: domestic quality drinking water, acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated site of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
21 days
reading time points: 1, 24, 48, 72 hours and 7, 14 and 21 days after removal of the test substance
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the back
- Type of wrap if used: gauze patches secured with Gothaplast tape and fixed wrapping the tape around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with soap and lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1+#2
Time point:
other: mean over 24, 48 and 72 hours
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
One hour after termination the first animal showed a well-defined erythema and a very slight edema. The second animal showed very slight edema and erythema and the third animal showed very slight erythema. All animals showed severe to well-defined erythema and only slight edema. After 48 hours all animal showed erythema and edema ranging from slight to severe. At 72 hours all animals showed moderate to severe erythema and only slight edema. On day 7 scale formation of the whole area was seen for all animals. After 14 days scales were still visible. After 21 days normal hair growth and intact skin were found for all animals.

Any other information on results incl. tables

Table1: Overview of individual scores

 Observation time  Rabbit No.               
   1     2     3   
   Erythema  Edema  Erythema  Edema  Erythema  Edema
 1 h  2  1  1  1  1  0
 24 h  3  3  3  3  2  2
 48 h  3  2  3  3  2  2
 72 h  3  2  3  2  2  2
 mean 24 - 72 h  3  2.33  3  2.67  2  2
 mean 24 - 72 h all animals  2.67  2.33        

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: Xi, R38
CLP: Category 2, H315