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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:
2006-02-20 to 2006-02-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The in vivo test was performed before the REACH regulation came into force, requesting in vitro studies. This information is used for read across to Terpene hydrocarbon alcohols

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Dertol 90
- Substance type: multi-constituent
- Physical state: liquid
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gerome, Linxe, France
- Weight at study initiation: between 2.15 and 2.57 kg
- Housing: individual box installed in conventional air conditioned
-Diet(ad libitum): supplied by UAR, Villemoison s/Orange, France, ad libitum
-Water(ad libitum): tap water from public distribution system, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20 and 22
- Humidity (%): between 30 and 37
-Air changes: at least 10 cycles per hour
-Photoperiod (hours dark / hours light): 12/12

IN-LIFE DATES: From: 2006-02-20 To: 2006-02-26

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 hours, no washing done
Observation period (in vivo):
Observations performed at 1, 24, 48 and 72 h up to 21 days
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: According to the scale of lesion scores published in Directive n° 2004/73/EC and OECD guideline n°405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Remarks:
conjunctiva
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Remarks:
lesion
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Remarks:
conjunctiva
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Remarks:
lesion
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Remarks:
conjunctiva
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Remarks:
lesion
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Moderate redness at the conjunctival level associated with moderate chemosis and moderate opacity at the corneal level. All effects were totally reversible within the 7th day at the latest.

Any other information on results incl. tables

Table 1: individual and mean scores of Conjunctivae, Iris and Cornea

Animal 

Time after treatment

CONJUNCTIVAE

IRIS

CORNEA

CHEMOSIS (A)

REDNESS (C)

LESION (D)

OPACITY (E)

A 7230

24 hours

1

2

0

2

48 hours

1

2

0

2

72 hours

1

2

0

2

TOTAL

MEAN

3

6

0

6

1.0

2.0

0.0

2.0

A 7231

24 hours

1

2

0

2

48 hours

1

2

0

2

72 hours

1

1

0

2

TOTAL

3

5

0

6

MEAN

1.0

1.7

0 .0

2.0

A 7232

24 hours

2

2

0

2

48 hours

2

1

0

0

72 hours

1

1

0

0

TOTAL

5

4

0

2

MEAN

1.7

1. 3

0.0

0.7

Applicant's summary and conclusion

Interpretation of results:
other: Eye irritant Cat. 2
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The occular reactions observed during the study have been moderate. The individual mean scores for conjunctival chemosis were 1.0, 1.0 and 1.7, conjunctival redness scores were 2.0, 1.7 and 1.3, cornea opacity scores were 2.0, 2.0 and 0.7 and iris lesion scores were 0.0 for all animals. At the conjuctivae level, a moderate redness, noted 24 h after the test item installation and totally reversible between the 6th and 7th day of the test, was associated with a moderate chemosis, noted 1h after the test item instillation and totally reversible between the 5th and 6th day of the test. At corneal level, moderate opacity was observed 24 h after the test substance administration and totally reversible between the 3rd and 6th day.
Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy adults female rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted Terpineol multi in one eye while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded (scale of lesion scores according to Directive n° 2004/73/EC and OECD guideline 405).

The occular reactions observed during the study have been moderate. The individual mean scores for conjunctival chemosis were 1.0, 1.0 and 1.7, conjunctival redness scores were 2.0, 1.7 and 1.3, cornea opacity scores were 2.0, 2.0 and 0.7 and iris lesion scores were 0.0 for all animals. At the conjuctivae level, a moderate redness, noted 24 h after the test item installation and totally reversible between the 6th and 7th day of the test, was associated with a moderate chemosis, noted 1h after the test item instillation and totally reversible between the 5th and 6th day of the test. At corneal level, moderate opacity was observed 24 h after the test substance administration and totally reversible between the 3rd and 6th day. Under these test conditions, Terpineol multi is considered as irritating to eyes, Cat 2.