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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Rapporteur for the EU risk assessment of (3-chloro-2-hydroxypropyl)trimethylammonium chloride is the National Product Control Agency for Welfare and Health, Finland. The report is the result of in-depth work performed by experts in one Member State, working with counterparts in other Member States, Industry and public interest groups. The information reported is considered reliable.

Data source

Reference
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
580mg (using a density of 1.16 g/ml).
Duration of treatment / exposure:
4 hours
Observation period:
The skin was examined 30 minutes after the removal of the patches and on days 2, 3 and 4.
Number of animals:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Time point:
other: 30 minutes
Score:
0
Irritation parameter:
overall irritation score
Time point:
other: 2 days
Score:
0
Irritation parameter:
overall irritation score
Time point:
other: 3 days
Score:
0
Irritation parameter:
overall irritation score
Time point:
other: 4 days
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance (3-chloro-2-hydroxypropyl)trimethylammonium chloride is not irritating to rabbit skin.
Executive summary:

In a study conducted according to EU guideline, three New Zealand White rabbits received a 0.5ml dose of 65% (3-chloro-2-hydroxypropyl)trimethylammonium chloride in water to a shaved region in the dorso-lumbar area. The test substance was applied to an area of 2.5cm2. The patch was semi-occluded with an adhesive dressing for 4 hours. After the removal of the semi-occlusive dressing the application area was washed. The skin was examined 30 minutes after the removal of the patches and on days 2,3 and 4. The scores were zero at all time points. The substance is not irritating to rabbit skin.