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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 Oct - 01 Nov 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2004
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosyl docosanoate
EC Number:
241-646-5
EC Name:
Docosyl docosanoate
Cas Number:
17671-27-1
Molecular formula:
C44H88O2
IUPAC Name:
docosyl docosanoate
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands BV, Horst, The Netherlands
- Age at study initiation: 12 weeks (male), 13 weeks (females)
- Weight at study initiation: not specified
- Housing: Individually in stainless steel cages with feed hoppers and drinking water bowls, enriched with wood blocks (RCC Ltd, Fullinsdorf, Switzerland) and haysticks 4642 (batch no. 08107, Provimi Kliba AG, Kaiseraugst, Switzerland)
- Diet: Provimi Kliba 3418 rabbit maintenance diet, batch no. 52/07 (Provirni Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: Under laboratory conditions after health examination, period not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 24 Oct 2007 To: 01 Nov 2007

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h
Number of animals:
1 male, 2 females
Details on study design:
TEST SITE
- Area of exposure: 100 cm2 on the left flank
- % coverage: not specified
- Type of wrap if used: The treated skin was covered with a surgical gauze patch held in place with a semi-occlusive dressing. The dressing was wrapped around the abdomen and secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with lukewarm water
- Time after start of exposure: 4 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test item did not induce any skin reactions in any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Other effects:
- Other adverse local effects: The test substance did not cause any skin alterations and did not cause irritative or corrosive effects.
- Other adverse systemic effects: No clinical signs of systemic toxicity were observed during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
A reliable study conducted in accordance with OECD guideline 404 and GLP found the test material to be non-irritating to the skin of rabbits. No skin reactions were observed at any observation time point. Erythema and edema scores were all 0.