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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well performed GLP and OECD guideline study
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well performed GLP and OECD guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Animal specifics: strain HC
- Age at study initiation: adult
- Weight at study initiation: 3,4 kg to 3,9 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet: standard laboratory diet (Ssniff K 4) Appr. 100 -120 g once per day in the morning
- Water: tap water, ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): 10 times
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm2
- Type of wrap if used: hypoallergenic patch (Beiersdorf AG)
A further patch serving as control was moistened with water and placed on the opposite dorso-lateral areas of the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: DRAIZE
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Irritant / corrosive response data:
no signs of irritation at any time
Other effects:
no other effects reported
Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) 1272/2008
Conclusions:
Based on the findings in this study the test item has to be regarded as not irritating to skin.

Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48, 72 hours and 7 days after removal of the dressing. No signs of corrosion/irritation were observed at any reading time. The test item therefore has to be regarded as not irritating to skin.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Barbitursäure, rein, trocken

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Animal specifics: strain HC
- Age at study initiation: adult
- Weight at study initiation: 2,7 kg to 3,8 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet: standard laboratory diet (Ssniff K 4) Appr. 100 -120 g once per day in the morning
- Water: tap water, ad libitum
- Acclimation period: at least 14 days



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): 10 times

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remained untreated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL equivalent to approx. 60 mg
Duration of treatment / exposure:
Single administration
Exposure period: 24 hours after instillation of the test substance the treated eye was rinsed with saline
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Application of the substance to the conjunctival sac of one eye of each animal, the other eyes served as control respectively

REMOVAL OF TEST SUBSTANCE

- Washing: 24 hours after instillation of the test substance the treated eye was rinsed with saline.


TOOL USED TO ASSESS SCORE: 1 % solution of fluorescein, under UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no signs of irritation (conjunctivae) at any time
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (chemosis) at any time
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
discharge was observed from 1 until 72 h after application.
All signs of irritation were fully reversible within 7 days.
Other effects:
No other effects reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) 1272/2008
Conclusions:
Testing of barbituric acid for primary eye irritation in the rabbit showed that the substance has not to be regarde as irritating to the eye.
Executive summary:

A study with the test item according to OECD Guideline 405 was performed to investigate the irritation potential to the rabbit eye.

The test item caused slight reactions of conjunctivae and corneae of the animals. Additionally, eye discharge was observed in the animals one hour after treatment until 72 h. 7 days after treatment all signs of irritation were fully reversible.

Testing of barbituric acid for primary eye irritation in the rabbit showed that the substance has not to be regarde as irritating to the eye.