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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
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:
other: Draize Test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml 55% (3-chloro-2-hydroxypropyl)trimethylammonium chloride solution in water.
Duration of treatment / exposure:
Each animal was treated by instillation of 0.1 ml of the test substance into one eye. The other eye remained untreated and served as a control.
Observation period (in vivo):
Approximately 24, 48, 72 hours and 7 days after instillation of the test substance.
Number of animals or in vitro replicates:
Six

Results and discussion

Any other information on results incl. tables

The US FDA scoring scale was used to assess cornea opacity, iris integrity and conjunctivae redness and chemosis.

All the scores were zero after 24 and 48 hours except in one animal that had a redness score of 1 on a Draize scale of 0 to 4 at 24 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: US FDA standards
Conclusions:
The substance (3-chloro-2-hydroxypropyl)trimethylammonium chloride is not irritating to the rabbit eye.
Executive summary:

The eye irritation potential of (3 -chloro-2 -hydroxypropyl)trimethylammonium chloride was assessed using six New Zealand White rabbits. The test substance (0.1 ml, 55% solution in water) was applied to one eye of each rabbit. The other eye remained untreated and served as a control. The eyes were not washed and were examined at 24, 48, 72 hours and 7 days after the instillation of the test substance. The US FDA scoring scale was used to assess cornea opacity, iris integrity and conjunctivae redness and chemosis.

All the scores were zero after 24 and 48 hours except in one animal that had a redness score of 1 on a Draize scale of 0 to 4 at 24 hours. The substance (3-chloro-2-hydroxypropyl)trimethylammonium chloride is not irritating to the rabbit eye.