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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:
02/08/1988-09/08/1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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
Study period:
02/08/1988-09/08/1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981-05-12
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: during the conduct of study the stability of the test material was warrented.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd.
- Weight at study initiation: 2.8 to 3.4 kg
- Housing: singly in wire cages Typ III-high
- Diet (ca. 100 to 200 g/animal/day): standard diet "ssniff K 4" (manufacturer: Ssniff Spezialdiäten GmbH, Soest/Westfalen)
- Water (ad libitum between 7 am and 7 pm): drinking water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 2 °C
- Relative humidity: ~50%
- Air changes: 10/hrs
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test material was moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: skin area (6 x 6 cm) at the flank was shaved with an electric hair clipper the day before test item application.
- Type of wrap if used: test material moistened with water was applied to a Hansamed band-aid hypoallergen (Beiersdorf No. 2342). The treated skin area comprises about 6 cm². Another band-aid was moistened with the vehicle. The prepared band-aids were placed on the opposing flanks of each animal and fixed with an elastic adhesive bandage (Fixomull-Stretch Klebevlies, Beiersdorf No. 2039). If the experimental conditions make it necessary, another fixation with Leukoplast-porös (Beiersdorf No. 1524) was considered.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by washing with water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours as well as 7 days after test item application

SCORING SYSTEM: according to Draize scale
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of dermal irritation were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not irritating to the skin.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not irritating to the skin.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981-05-12
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
The test material: Chromoxyd Dyko
- State of aggregation: green powder
- pH: 7 - 8
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: during the conduct of study the stability of the test material was warrented.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd.
- Weight at study initiation: 3.1 to 3.4 kg
- Housing: singly in wire cages Typ III-high
- Diet (ca. 100 to 200 g/animal/day): standard diet "ssniff K 4" (manufacturer: Ssniff Spezialdiäten GmbH, Soest/Westfalen)
- Water (ad libitum between 7 am and 7 pm): drinking water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 2 °C
- Relative humidity: ~50%
- Air changes: 10/hrs
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (equivalent to approximately 50 mg) was instilled into the conjunctival sac of one eye. The untreated eye served as control.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Duration of post- treatment incubation (in vitro):
not applicable
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes were washed with physiological saline.
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize scale
Observations were recorded 1, 24, 48, and 72 hours as well as 7 days following test item application.
Furthermore, the lacrimation and the aqueous humour were examined.

TOOL USED TO ASSESS SCORE:
Corneal effects were additionally investigated using fluorescein. Furthermore, a light source was used for examination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Irritant effects were limited to Grade 1 conjunctival erythema in two animals at the one-hour observation only. All reactions had resolved by 24 hours.
Other effects:
No additional effects were observed.

Any other information on results incl. tables

Observation

1h

24h

48h

72h

Mean

(24-72h)

7 days

Cornea

Opacity

0.00

0.00

0.00

0.00

0.00

0.00

Iris

0.00

0.00

0.00

0.00

0.00

0.00

Conjunctivae

Erythema

0.67

0.00

0.00

0.00

0.00

0.00

Chemosis

0.00

0.00

0.00

0.00

0.00

0.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not irritating to the eyes.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not irritating to the eyes.