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EC number: 619-547-7 | CAS number: 211515-46-7
Skin irritation / corrosion
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:
- 2 006
- 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
- 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.
Constituent 1
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.
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