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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:
supporting study
Study period:
17 Jul - 10 Sep 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 April 2002
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008, L142, Annex Part B
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
BAYRISCHES LANDESAMT FÜR GESUNDHEIT UND LEBENSMITTELSICHERHEIT, LANDESINSTITUT FÜR ARBEITSSCHUTZ UND PRODUKTSICHERHEIT, München, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand White Rabbits, Crl:KBL (NZW)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 20 weeks
- Weight at study initiation: 3.5 - 4.6 kg
- Housing: Rabbits were housed individually in ABS - plastic rabbit cages with a floor of 4200cm²
- Diet: autoclaved hay and Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
The animals were derived from a controlled full-barrier maintained bredding system (SPF).

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr):at least 10 x
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 17 Jul 2011 To: 10 Sep 2011

Test system

Vehicle:
other: vaseline
Controls:
other: The untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration: 70% (v/v)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100%
- Lot/batch no. (if required): 1004025-01
Duration of treatment / exposure:
24 h
Observation period (in vivo):
up to 11 days
Reading time points: 24, 48 and 72 h and every 24 h for up to 11 days
Number of animals or in vitro replicates:
4 females (including 1 animal for the preliminary test)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with physiological saline 0.9% NaCl
- Time after start of exposure: 24 h

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24,48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: evaluated after fluoresceine application
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 11 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
The test item produced irritant ocular effects after application in 3 animals.
Conjunctival rednesses, chemosis and discharge were observed in 3 animals.
Upon fluoresceine examinations, corneal lesions were determined in 2 animals after 72 h.

A 70% mixture of octanoic acid in vaseline induced lesions of the iris in 2 out of 3 tested animals with a score equal to 1. Therefore, the test item has to be considered as eye irritant at a concentration of 70%.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed (table 2).

Any other information on results incl. tables

Table 2: Clinical signs of toxicity

 

 

Time after application

Systemic findings

Local findings

animal 1

1 – 72 h

no specific findings

mild discharge

4 – 6 days

no specific findings

slight discharge

7 – 9 days

no specific findings

no specific findings

animal 2

1 h

no specific findings

mild discharge

24 h

no specific findings

slight discharge

48 h – 6 days

no specific findings

no specific findings

animal 3

1 h – 24 h

no specific findings

mild discharge

48 h

no specific findings

severe discharge

72 h

no specific findings

slight discharge

4 – 5 days

no specific findings

no specific findings

6 and 8 days

no specific findings

slight discharge

9 – 11 days

no specific findings

no specific findings

Table 3: Absolute body weight (kg)

 

 

animal 1

animal 2

animal 3

start of study

4.4

4.6

3.5

72 h post application

4.6

4.7

3.4

end of observation period

4.5

4.6

3.5

Applicant's summary and conclusion

Interpretation of results:
other: Eye Cat. 2, H319 at a concentration of 70% according to Regulation (EC) No 1272/2008
Conclusions:
CLP: Eye irritation, Cat. 2, H319 at a concentration of 70%