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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:
September 26 - October 04, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
April 2002
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Termamyl SC, PPY23880
- Substance type: UVCB
- Physical state: liquid
- Lot/batch No.: PPY 23880
- Expiration date of the lot/batch: At least stable until 20 April 2014
- pH = 7.6
- Stability under test conditions: The test material is stable for at least 24 hours at room temperature
- Storage condition of test material: minus 20 degrees of Celcius

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred by Charles River, Germany
- Age at study initiation: Adults
- Weight at study start: 1956 - 2064 g
- Housing: individually in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): Standard diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23°C
- Humidity (%): 50-70 %
- Air changes (per hr): 10 air changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark cycle

IN-LIFE DATES: From: 2007-10-01 To: 2007-10-04



Test system

Vehicle:
other: Tested neat
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test material, i.e. 60 mg total protein/mL

Observation period (in vivo):
The reactions were judged 1, 24, 48 and 72 hours after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing


SCORING SYSTEM: According to OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
At the 1 hour reading, discharge was present (score 1) in rabbit # 1. However, this symptom had disappeared at the following observations (24, 48 and 72 hours after treatment). At the examination at 1 hour and 24 hours after exposure, slight redness with or without slight swelling of the conjunctivae was present (score 1) in the three rabbits. However, these eye effects had cleared completely at the following observations, 48 and 72 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material alpha-amylase is not irritating to eyes.
Executive summary:

The study was carried out according to OECD guideline no. 405. Three rabbits were treated as follows: One rabbit was treated first and two more aprox. one hour later. An amount of 0.1 mL of the undiluted test substance was instilled in the conjunctival cul-de-sac of one of the eyes of the rabbit. After administration, the upper and the lower eye lid were carefully closed and subsequently held together for at least one second before releasing to prevent loss of material. The other eye remained untreated and served as a control. The reactions of the eyes were judged at 1 h, 24 h, 48 h and 72 h after treatment.

The only effects seen were ocular discharge (score 1) in one rabbit at the 1 hour reading, and slight redness with or without slight swelling of the conjunctivae (score 1) in all rabbits at the examination at 1 hour and 24 hours after exposure. However, these slight effects were cleared completely at the following observations 48 and 72 hours after treatment. According to the Globally Harmonised System of Classification and labelling of Chemicals (GHS, UN/ECE 2003) alpha-amylase should not be classified as eye irritating.