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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:
From December 3, 1985 to February 19, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal regulations, title 16, § 1500.42
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
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): Maltogen amylase, SP 295, batch no. PPY 1624
- Substance type: UVCB
- Physical state: Liquid
- Lot/batch No.: PPY 1624
- Expiration date of the lot/batch: At least stable until 1994-07-05
- Stability under test conditions: The test material is stable for at least 4 hours at room temperature
- Storage condition of test material: 4 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 Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: Males (average): 3.2 kg, females (average): 3.5 kg
- Housing: Individually in galvanized steel cages with mesh floor.
- Diet : Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: The animals were bred in-house

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 35-60%

IN-LIFE DATES: From: 1985-12-03 To: 1985-12-10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Concentration: undiluted
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped.
Duration of treatment / exposure:
The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The other eye, remaining untreated, serves as a control.
Observation period (in vivo):
The reactions were observed at 1, 24, 48, 72 hours and 7 days after instillation of the test material.
Number of animals or in vitro replicates:
3 female and 3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: The ocular reactions were recorded 1, 24, 48, 72 hours and 7 days after instillation of the test material.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #19, #21, #22, #23, #24
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #20
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(ulceration)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No corneal opacity or iris reactions were noted at any time during the test. Only very slight redness of the conjunctiva of animal #23 at 1 hour and of animal #20 at 24 hours were observed.
All signs were reversible within 48 h.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, maltogen amylase can be classified as a ‘non irritant’ to the rabbit eye.
Executive summary:

Maltogen amylase, was instilled in the conjunctival sac of 6 rabbits in order to examine the irritation potential to the eyes. The untreated eye served as control. The ocular reactions were recorded at 1, 24, 48, 72 hours and 7 days after instillation according to the specified guideline.

No corneal opacity or iris reactions were noted at any time during the test. Only very slight redness of the conjunctiva of animal #20 at 24 hours was observed, however, this was fully reversible within 48 hours. All signs were reversible, and no reactions were seen after 48 or 72 hours, or after 7 days.

In conclusion, maltogen amylase can be classified as a 'non-irritant' to the eyes.