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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
The study was performed between 31 January 2008 and 08 February 2008.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 21/8/2007. Date of signature: 15/10/2007

Test material

Constituent 1
Reference substance name:
-
EC Number:
482-220-0
EC Name:
-
Cas Number:
848301-69-9
IUPAC Name:
1-(2-methylpentyl)-3-(6-methylundecyl)cyclopentane; 1-(3,7-dimethyldecyl)-3-(2-methylbutyl)cyclohexane; 1-(3-methyldecyl)-3-(2-methylpentyl)cyclohexane; 4,8,11-trimethylpentadecane; 6,9-dimethylhexadecane; 6-methylheptadecane

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation:2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23°C.
- Humidity (%): The relative humidity was set ti achieve limits of 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continous light and twelve hours darkness.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the test material.


Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patch, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the 4 hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after application the corset and patch were removed from the animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: Four hours

SCORING SYSTEM:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale (see below):

Other:
Measurement of pH:
The pH of the test material was determined prior to commencement of the study and found to be as follows:
90% v/v aqueous preparation of the test material - pH: approx 8.9 immediately, approx 8.6 after 10 minutes.





Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
: animal 67060 (female)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
: animal 67162 (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
: animal 67163 (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
: animal 67060 (female)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
: animal 67162 (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
: animal 67163 (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No evidence of skin irritation was noted during the study.
Other effects:
No corrosive effects were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC (Dangerous Substances Directive).
The test material did not meet the criteria for classifcation as a skin irritant according to EU CLP regulations.
Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test material ‘Distillates (Fischer-Tropsch), heavy, C18-50 - branched, cyclic and linear’ to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)

• Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results.

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.

Conclusion.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC (Dangerous Substances Directive).

The test material did not meet the criteria for classifcation as a skin irritant according to EU CLP regulations.