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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Reference substance name:
Dodecene, hydroformylation products, high-boiling
EC Number:
271-239-8
EC Name:
Dodecene, hydroformylation products, high-boiling
Cas Number:
68526-91-0
Molecular formula:
Unspecified
IUPAC Name:
Reaction products of dodecene, hydroformylation products, high boiling
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 or test system 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.