Carbamic acid, [(1S,2S)-3-chloro-2-hydroxy-1-(phenylmethyl)propyl]-, methyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

March 20, to May 18, 1955

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to GLP and was designed to meet OECD guideline 405 for assessing acute ocular irritation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Chlorohydrine

IUPAC Name:

Chlorohydrine

Constituent 2

Reference substance name:

(1S,2S)-(1-Benzyl-3-chloro-2-hydroxy-propyl)-carbamic acid methyl ester

IUPAC Name:

(1S,2S)-(1-Benzyl-3-chloro-2-hydroxy-propyl)-carbamic acid methyl ester

Details on test material:

Chemical Name: (1S,2S)-(1-Benzyl-3-chloro-2-hydroxy-propyl)-carbamic acid methyl ester
Physical State: Solid
Source: Syntex Group Technology Center, Boulder, Colorado
Storage: Room temperature
GLP Status: GLP

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye served as an untreated control

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

up to7 days after treatment

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Other effects:

Results:
Slight conjunctival chemosis and/or iridial changes were observed in all rabbits 1 hour postdosing. Slight to moderate conjunctival redness, chemosis, and iridial changes were seen in 2 rabbits 24 hours postdosing. Seventy-two hours postdosing, iridial changes were no longer observed. All rabbits were normal 7 days postdosing.

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Although Ro 61-4022 caused slight reversible irritation to the eye, it is not considered an ocular irritant under the test conditions and under EU and OECD criteria and thus, no labeling for eye irritation potential is required under EU regulatory criteria.

Executive summary:

Purpose: The Environmental Health and Safety Division have requested that safety evaluation studies be performed with Chlorohydrine. The study was conducted according to GLP and was designed to meet OECD guideline 405 for assessing acute ocular irritation.

Unless otherwise stated, all procedures were conducted according to Syntex Standard Operating Procedures. No unforeseen circumstances affected the quality or the integrity of the study. The raw data and report for this study are maintained in Syntex archives managed from 3401 Hillview Avenue, Palo Alto, California.

Study Design: Three male rabbits each received a single dose of 0.1 g of Chlorohydrine that was placed into the conjunctival sac of the right eye of each rabbit. The left eye served as an untreated control. Following the 24-hour postdosing eye examination, both eyes of each rabbit were rinsed with an isotonic saline solution. The eyes were examined for signs of irritation approximately 1, 24, 48, and 72 hours; and 7 days after treatment, and scored according to a modification of the Draize method at these time periods.

Results: Slight conjunctival chemosis and/or iridial changes were observed in all rabbits 1 hour postdosing. Slight to moderate conjunctival redness, chemosis, and iridial changes were seen in 2 rabbits 24 hours postdosing. Seventy-two hours postdosing, iridial changes were no longer observed. All rabbits were normal 7 days postdosing.

Conclusion: Although Ro 61-4022 caused slight reversible irritation to the eye, it is not considered an ocular irritant under the test conditions and under EU and OECD criteria and thus, no labeling for eye irritation potential is required under EU regulatory criteria.