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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, occlussive dressing (standard application conditions at the beginning of the 80s)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oxooel 13
- Physical state: liquid, clear
- Composition of test material: mixture of C13-alcohols, C13-acids and -esters
- Stability under test conditions: yes

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: no data
- Weight at study initiation: male: 3.46 kg; mean female: 3.09 kg
- Housing: single
- Diet: about 130 g per animal and day (Ovator Solikanin 4 mm)
- Water: about 250 ml per animal and day
- Acclimation period: about 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: about 0.5 ml



Duration of treatment / exposure:
4 hrs
Observation period:
8 days
Number of animals:
3 (one male, two females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hrs


SCORING SYSTEM: as described in OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/48/72 hrs
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/48/72 hrs
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24/48/72 hrs
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
no edema observed; scale formation in all three animals on day 8
Other effects:
histopathologic observations: no abnormalities detected

Any other information on results incl. tables

Exposition:  4 hrs
Animal  Reading  Erythema Edema Symptoms
1 24 hrs 2 0 overall redness
2 24 hrs 2 0 overall redness
3 24 hrs 2 0 overall redness
1 48 hrs 2 0 overall redness
2 48 hrs 2 0
3 48 hrs 1 0 overall redness
1 72 hrs 1 0 overall redness
2 72 hrs 2 0
3 72 hrs 1 0 overall redness
1 8 d 0 0 scale formation
2 8 d 0 0 scale formation
3 8 d 0 0 scale formation
mean (animal 1-3) 24/48/72 hrs 1.7 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oxooel 13 has not to be classified according to EU and GHS EU.
Executive summary:

The study is conducted according to OECD 404 and reliable (deviation: occlusive dressing). A cloth (2.5 x 2.5 cm) soaked with test substance (about 0.5 ml) was applied onto the skin of two rabbits. After 4 hrs the test substance was washed away. Erythema (score >/= 1.5 to 2.3) in two of three animals and scale formation at the end of the ovbservation period of 8 days were observed.

Conclusion:

Oxooel 13 has not to be classified according to EU and GHS EU.