Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
September 20,2006 to December 11 , 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study followed the procedures indicated by the following internationally accepted guidelines and recommendations: First Addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 404, “Acute Dermal Initation/Corrosion” adopted 24th April, 2002. Directive 92/69 EEC B.4. EPA Health Effects Test Guidelines, OPPTS 870.2500 “Acute dermal irritation”, EPA 712-C-98-196, (August 1998).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
and EU Method B.40 (Skin Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2-ethylbutyl)cyclohexanecarbonyl chloride
EC Number:
619-547-7
Cas Number:
211515-46-7
Molecular formula:
C13 H23 Cl O
IUPAC Name:
1-(2-ethylbutyl)cyclohexanecarbonyl chloride
Details on test material:
Name: CAT-Acid chloride
CAS No.: 211515-46-7
Storage: refrigerator +2 to +8 degree C
Safety precautions: Routine hygienic procedures were sufficient
to assure personnel health and safety.
Due to the oily consistency of the test item the pH-value was not determinable.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
Test item was held in contact with the skin throughout a 4-hour period. At
the end of the exposure period, residual test item was removed by using tap
water.
Observation period:
Animals were examined for signs of erythema and oedema at 1, 24, 48 and
72 hours after patch removal.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all time points from 1 hour to 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours.
Irritation parameter:
other: body weight
Remarks on result:
other: There were no significant body weight changes during the contact and observation period

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information nor corrosive Criteria used for interpretation of results: other: Guidelines in Commission Directive 93/21 EEC
Conclusions:
Considering the reported data of this irritation study it can be stated that the
test item CAT-Acid chloride showed no irritant/corrosive effects.
According to the EC criteria for classification and labelling requirements for
dangerous substances and preparations (Guidelines in Commission Directive
93/21 EEC) the test item CAT-Acid chloride does not have to be classified
and has no obligatory labelling requirement for skin irritation.
Executive summary:

Title:

Acute Dermal Irritation/Corrosion with CAT-Acid chloride

 

Guidelines:

The study was done at BIOSERVICE according to OECD No. 404 (adopted 24th April,

2002), EC Directive 92/69 8.4 and in compliance with GLP regulations.

 

Material & Methods:

Species/strain: New Zealand White Rabbits HsdIf:NZW

Number of animals: 3

Duration of exposure: 4 hours

Amount of substance: 0.5 g per test site

Type of dressing: semi-occlusive

Vehicle (moistening): no vehicle used

Reversibility of any observed effect: No effects observed.

Method: OECD 404 92 / 69 / EEC B.4 OPPTS 870.2500

 

Results:

The test item showed neither irritation nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours. There were no significant body weight changes

during the contact and observation period.

 

Conclusion:

Considering the reported data of this irritation study it can be stated that the

test item CAT-Acid chloride showed no irritant/corrosive effects.

According to the EC criteria for classification and labelling requirements for

dangerous substances and preparations (Guidelines in Commission Directive

93/21 EEC) the test item CAT-Acid chloride does not have to be classified

and has no obligatory labelling requirement for skin irritation.