Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Citronellyl acetate
EC Number:
205-775-0
EC Name:
Citronellyl acetate
Cas Number:
150-84-5
IUPAC Name:
3,7-dimethyloct-6-en-1-yl acetate
Test material form:
liquid
Details on test material:
Designation: CITRONELLYL ACETATE EXTRA
Appearance: colourless to pale yellowish liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR. K. Thomae GmbH, Biberach
- Age at study initiation: young adult
- Animal identification: ear tattoo
- Weight at study initiation: female: 3.76 kg; male: 3.41 and 3.48 kg
- Housing: single housing, stainless stell wire mesh cages with grating, floor area: 3000 cm2
- Bedding: no bedding in the cages; sawdust in the waste trays
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Tap Water (about 250 ml/animal/day)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 ml on intact untreated skin
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3
Details on study design:
TEST SITE
- Preparation: at least 24 h before the test, the fur was removed by clipping the dorsal of the trunk of the animal; only animals with healthy/intact skin were used
- Area of exposure: upper third of back or flanks
- Application: 2.5 x 2.5 cm test patch moistened with 0.5 ml of the test substance
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adheasive Fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (BASF SE) and Lutrol in water (1:1)
- Time after start of exposure: 4 h

READING
- 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after patch removal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

For calculation of the means only the 24, 48 and 72 hours readings were taken into consideration.

Irritant response data:

Readings Animal Exposure period: 4 h
Erythema Edema Additional findings
1h 1 2 1  
2 2 1  
3 2 1  
24 h 1 3 2  
2 3 1  
3 3 1  
48 h 1 3 1  
2 2 1  
3 2 1  
72 h 1 3 0  
2 2 0  
3 2 0  
8 d 1 1 0 scaling
2 0 0 scaling
3 0 0 scaling
15 d 1 0 0 scaling
2 0 0  
3 0 0  
Mean 24 - 72 h 1 3 1  
2 2.3 0.7  
3 2.3 0.7  
Mean   2.5 0.8  

Animal 1: female; animal 2: male; animal 3: male

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
According to the study, the test subtance was found to be irritant on rabbits and is classified as Category 2.