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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:
29 Oct - 16 Nov 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted 2004
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
adopted Aug 1998
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No. 8147, November 2000, including the most recent partial revisions
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: powder aggregated into lumps
Details on test material:
- Name of test material (as cited in study report): SPM-N
- Physical state: white lumps with powder
- Lot/batch No.: T-9314
- Expiration date of the lot/batch: 29 Aug 2008
- Storage condition of test material: at room temperature in the dark
- Other: pH 7.6-7.5 (1% in water, indicative range)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, the Netherlands
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 2.02-2.10 kg
- Housing: animals were housed individually in cages (56 cm x 44 cm x 37,5 cm) with perforated floors (Scanbur, Denmark)
- Diet: K-H pelleted diet for rabbits (SSNIFF Spezialdiäten GmbH, Soest, Germany), approximately 100 g/day. Hay (Technilab-BMI BV, Someren, the Netherlands) was provided at least 3 times/week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9-22.6
- Humidity (%): 44-56%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 Oct 2007 To: 16 Nov 2007

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required: the untreated eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 44.0 mg (range 36.9-47.7 mg) (corresponding to a volume of approximately 0.1 mL)
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 2% fluorescein was instilled in the eyes immediately after the 24 h reading and the corneal epithelial damage assessed with a slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
Conjunctival redness (score 2) was observed in 3/3 animals 1 h after instillation. The redness persisted in 3/3 animals (score 1) until the 48 h reading time point. Chemosis (score 1-2) was observed in 3/3 animals and iridial irritation (score 1) was seen in 2/3 animals at the 1 h reading time point. Both effects had cleared completely by the 24 h reading. All effects were completely reversible within 72 h.
Remains of the test substance were noted in the treated eye of 3/3 animals on Day 1, while remains were present on the outside of the eyelids on Day 2 in 1/3 animals.
Other effects:
There was no mortality, no clinical signs were observed and the body weight was within the normal range during the study period.

Any other information on results incl. tables

Table 1: individual irritation scores

Rabbit #

 

Time

 

conjunctivae

 

iris

 

cornea

 

redness

chemosis

1

 

 

 

 

1 h1

2

1

1

0

24 h

1

0

0

0

48 h

1

0

0

0

72 h

0

0

0

0

Average*

0.67

0.0

0.0

0.0

2

 

 

 

 

1 h1

2

2

0

0

24 h2

1

0

0

0

48 h

1

0

0

0

72 h

0

0

0

0

Average*

0.67

0.0

0.0

0.0

3

 

 

 

 

1 h1

2

1

1

0

24 h

1

0

0

0

48 h

1

0

0

0

72 h

0

0

0

0

Average*

0.67

0.00

0.0

0.0

* mean of 24 + 48 + 72 h

1Remains of test substance in the eye

2Remains of the test substance on the outside of the eyelids

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified