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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 August - November 24 1999
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Androstan-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl)-, 17-acetate (2α,3α,5α,16α,17β)-
EC Number:
601-596-0
Cas Number:
119302-24-8
Molecular formula:
C29H48N2O4
IUPAC Name:
Androstan-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl)-, 17-acetate (2α,3α,5α,16α,17β)-
Test material form:
other: Solid
Details on test material:
- Name of test material (as cited in study report): Pymorolac
- Physical state: Cream White Solid
- Analytical purity: >= 95%
- Purity test date:
- Lot/batch No.: DGN105K1A
- Expiration date of the lot/batch: 01 January 2001
- Stability under test conditions: Yes
- Storage condition of test material: At room temperature in the dark.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederland, Someren, the Netherlands
- Age at study initiation: At least 6 weeks
- Weight at study initiation: Less than 3.5 kg
- Housing: Individually in cages with perforated floors
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g per day.
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ˚C
- Humidity (%): 50%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 34.5 +/- 0.7 mg (volume of approximately 0.1 mL)
Duration of treatment / exposure:
48 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with approx 50 mL tepid tap-water
- Time after start of exposure: observations were done at 24 hrs and then the substance was rinsed from the eyes

SCORING SYSTEM: See "Any other information on materials and methods incl. tables".

TOOL USED TO ASSESS SCORE: Ophthalmic examination lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Animal 501
Time point:
other: 24-72 hours
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Animal 503
Time point:
other: 24-72 hours
Score:
ca. 0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Animal 513
Time point:
other: 24-72 hours
Score:
ca. 0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
Animal 501, 503, 513
Time point:
other: 24-72 hours
Score:
ca. 0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Animal 501
Time point:
other: 24-72 hours
Score:
ca. 2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Animal 503
Time point:
other: 24-72 hours
Score:
ca. 2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Animal 513
Time point:
other: 24-72 hours
Score:
ca. 1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Animal 501
Time point:
other: 24-72 hours
Score:
ca. 1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Animal 503
Time point:
other: 24-72 hours
Score:
ca. 1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Animal 513
Time point:
other: 24-72 hours
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Opacity and epithelial damage of the corneal was observed in two animals and was resolved within 7 days with one and 72 hours in the other. All animals reported iridial irritation, which was resolved within 72 hours.
Irritation of the conjunctivae was reported in all animals, this was resolved within 7 days in two animals and within 14 days in the other animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance is considered an eye irritant according to Regulation (EC) 1272/2008 (CLP) (H319) because at 2 of hte three animals tested had a conjunctival redness score greater than 2 (of a possible 4), which aligns with the GHS and CLP criteria for eye irritant Cat 2.