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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:
28 September 1998 to 02 October 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline N°405, GLP but substance analytical certificate not available (Substance identification: code name with information on test substance).
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
28 September 1998 to 02 October 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline N°405, GLP but substance analytical certificate not available (Substance identification: code name with information on test substance).
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
age of animals at study initiation was not reported
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
age of animals at study initiation was not reported
Principles of method if other than guideline:
Guideline study
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
other: SPF albino rabbits of the stock Mol:Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: M & B, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: kept individually in PPO/HIPS cages (Noryl, floor area = 2576 cm²)
- Diet: pelleted complete rabbit diet "Altromin 2123" from Ch. Petersen ad libitum. Analysis for major nutritive components and relevant possible contaminations in the diet are performed regularly.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 ad libitum. Analyses for relevant possible contamination in the water are performed regularly.
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): 10
- Photoperiod :12 hrs dark /12 hrs light


IN-LIFE DATES: From: To:
Vehicle:
not specified
Controls:
other: the right eye of the treated animals was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours after application
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hrs


SCORING SYSTEM: grading according to OECD 405 recommendation


TOOL USED TO ASSESS SCORE: fluorescein, UV light
Irritation parameter:
cornea opacity score
Basis:
other: mean individual score for all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritation parameter:
iris score
Basis:
other: mean individual score for all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritation parameter:
chemosis score
Basis:
other: mean individual score for all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #3 - Mean individual score
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24h, 48h, 72h
Score:
0.7
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritant / corrosive response data:
Irritant effects on conjunctiva (redness) were minimal at 1 hour in all animals and were fully reversed at 72h in all animals. There were no effects on the cornea and the iris at any time point. Chemosis was not observed at any time point in all animals.
It can be concluded that DV 98-25 would not be classified as eye irritant.
Other effects:
No data

Table 1: DV 98 -25 Acute eye irritation/corrosion study in the rabbit. Scores for ocular lesions.

Rabbit No /

1 h

24 hrs

 

48 hrs

72 hrs

Individual mean score*

weight (kg)

F

3531 / 2.3

Cornea opacity, area

0

0

0

0

0

 

Cornea opacity, degree

0

0

 0

0

0

0.0

Iris

0

0

 

0

0

0.0

Conjunctiva

Chemosis

0

0

 

0

0

0.0

Redness

1

0

 

0

0

0.0

Discharge

3

0

 

0

0

 

3533 / 2.3

Cornea opacity, area

0

0

0

0

0

 

Cornea opacity, degree

0

0

 0

0

0

0.0

Iris

0

0

 

0

0

0.0

Conjunctiva

Chemosis

0

0

 

0

0

0.0

Redness

1

1

 

1

0

0.7

Discharge

3

0

 

0

0

 

3534 / 2.8

Cornea opacity, area

0

0

0

0

0

 

Cornea opacity, degree

0

0

0

0

0.0

Iris

0

0

 

0

0

0.0

Conjunctiva

Chemosis

0

0

 

0

0

0.0

Redness

1

0

 

0

0

0.0

Discharge

3

0

 

0

0

0.0

F: Reading after instillation of oculoguttae fluoresceini.

* Only the scores from the 3 readings (24, 48 and 72 hours) are included in the calculation of the individual mean scores

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
under the test conditions, DV 98-25 is not classified as eye irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
Executive summary:

The eye irritant effect of DV 98-25 was investigated according to the OECD Guideline No. 405 (1987) and EEC B.5 method (1992) and in compliance with Good Laboratory Practice.

Three female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing.

Minimal conjunctival irritation (redness) was observed in the three rabbits 1 hour after dosing. During the rest of the observation period no abnormalities were observed for two animals while redness (score 1) was still observed up to 48 h in the third animal.

DV 98 -25 is not considered as irritating to the eyes according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
age of animals at study initiation was not reported
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
age of animals at study initiation was not reported
Principles of method if other than guideline:
Guideline study
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DV 98-25
- Substance type: Petroleum product, UVCB
- Physical state: Bright and clear colourless liquid
- Analytical purity: 100% Commercial product
- Composition of test material, percentage of components: Hydrocarbons , C I 4-C 18, n-alkanes, isoalkanes, cyclics, < 2% aromatics
- Storage condition of test material: the test article kept at room temperature in the dark.
- Reception date of the test article: 09 September 1998


Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino rabbits of the stock Mol:Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: M & B, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: kept individually in PPO/HIPS cages (Noryl, floor area = 2576 cm²)
- Diet: pelleted complete rabbit diet "Altromin 2123" from Ch. Petersen ad libitum. Analysis for major nutritive components and relevant possible contaminations in the diet are performed regularly.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 ad libitum. Analyses for relevant possible contamination in the water are performed regularly.
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): 10
- Photoperiod :12 hrs dark /12 hrs light


IN-LIFE DATES: From: To:

Test system

Vehicle:
not specified
Controls:
other: the right eye of the treated animals was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours after application
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hrs


SCORING SYSTEM: grading according to OECD 405 recommendation


TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean individual score for all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritation parameter:
iris score
Basis:
other: mean individual score for all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritation parameter:
chemosis score
Basis:
other: mean individual score for all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #3 - Mean individual score
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24h, 48h, 72h
Score:
0.7
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: See Table 1 for details
Irritant / corrosive response data:
Irritant effects on conjunctiva (redness) were minimal at 1 hour in all animals and were fully reversed at 72h in all animals. There were no effects on the cornea and the iris at any time point. Chemosis was not observed at any time point in all animals.
It can be concluded that DV 98-25 would not be classified as eye irritant.
Other effects:
No data

Any other information on results incl. tables

Table 1: DV 98 -25 Acute eye irritation/corrosion study in the rabbit. Scores for ocular lesions.

Rabbit No /

1 h

24 hrs

 

48 hrs

72 hrs

Individual mean score*

weight (kg)

F

3531 / 2.3

Cornea opacity, area

0

0

0

0

0

 

Cornea opacity, degree

0

0

 0

0

0

0.0

Iris

0

0

 

0

0

0.0

Conjunctiva

Chemosis

0

0

 

0

0

0.0

Redness

1

0

 

0

0

0.0

Discharge

3

0

 

0

0

 

3533 / 2.3

Cornea opacity, area

0

0

0

0

0

 

Cornea opacity, degree

0

0

 0

0

0

0.0

Iris

0

0

 

0

0

0.0

Conjunctiva

Chemosis

0

0

 

0

0

0.0

Redness

1

1

 

1

0

0.7

Discharge

3

0

 

0

0

 

3534 / 2.8

Cornea opacity, area

0

0

0

0

0

 

Cornea opacity, degree

0

0

0

0

0.0

Iris

0

0

 

0

0

0.0

Conjunctiva

Chemosis

0

0

 

0

0

0.0

Redness

1

0

 

0

0

0.0

Discharge

3

0

 

0

0

0.0

F: Reading after instillation of oculoguttae fluoresceini.

* Only the scores from the 3 readings (24, 48 and 72 hours) are included in the calculation of the individual mean scores

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
under the test conditions, DV 98-25 is not classified as eye irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
Executive summary:

The eye irritant effect of DV 98-25 was investigated according to the OECD Guideline No. 405 (1987) and EEC B.5 method (1992) and in compliance with Good Laboratory Practice.

Three female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing.

Minimal conjunctival irritation (redness) was observed in the three rabbits 1 hour after dosing. During the rest of the observation period no abnormalities were observed for two animals while redness (score 1) was still observed up to 48 h in the third animal.

DV 98 -25 is not considered as irritating to the eyes according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.