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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 - 20 August 1999
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks old
- Weight at study initiation: Mean less than 3.5 kg
- Housing: Individually in cages with perforated floors
- Diet: 100 g/day of Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany). Once/week hay was provided (BMI, HElmond, the Netherlands).
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: 5 days

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

IN-LIFE DATES: From: 1999-08-17 August To: 1999-08-20
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 grams
Duration of treatment / exposure:
4 Hours
Observation period:
72 Hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Flank
- coverage: 2x3 cm
- Type of wrap if used: Metalline patch mounted on Micropore tape and secured using Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: See free text field below
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 Hours
Score:
>= 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 Hours
Score:
>= 0
Max. score:
4
Irritant / corrosive response data:
No skin irritation or corrosion was caused by the 4 hours of exposure to the test substance at 0.5 grams.
Other effects:
No symptoms of systemic toxicity were observed in the rabbits during the test period and no mortality was reported.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance when administered as supplied to rabbits, at a dosage of 0.5 grams does not cause irritation/corrosion to the animals.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
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
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.
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
GLP study according to OECD Guideline 405. Pymorolac when administered as supplied to rabbits, at a dosage of 0.5 grams does not cause irritation/corrosion to the animals.

Justification for selection of eye irritation endpoint:
GLP study according to OECD Guideline404 and EU Method B.4. Under the conditions of this study, the test substance was not considered an eye irritant.

Justification for classification or non-classification