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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:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP conditions; it is considered to be reliable, relevant, but not adequate for classification, as the test was performed with a 10% solution of the test product (containing 39% of active ingredient).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 405 (February 24, 1987) and EEC directive 84/449 EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde, Neuendamm 88
- Age at study initiation: No data
- Weight at study initiation: 2.4-2.8 kg
- Fasting period before study: Not applicable
- Housing: Individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): Ad libitum, Ssniff MÜ Z® (Alleindiät für Zuchtkaninchen),manufactured by Ssniff spezialdiäten GmbH, 4770 Soest/ Westfalen, pellets, 1.0-1.5 cm long, 0.5 cm diameter
- Water (e.g. ad libitum): Ad libitum, drinking nipples, drinking water as for human consumption, analytical and bacteriological controls every six months
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2 °C (measured with thermohygrometer twice daily)
- Humidity (%): 50-85 % (measured with thermohygrometer twice daily)
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12 (artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.

Test system

Vehicle:
other: purified water (conductivity < 55 nS/cm)
Controls:
other: left eye was tested, right eye was used as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (not more than 100 mg)
- Concentration (if solution): 10 % v/v

Duration of treatment / exposure:
Eyes were not rinsed after treatment
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Grading of ocular lesions as stipulated by OECD 405

TOOL USED TO ASSESS SCORE: ophtalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
0.28
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5
Time point:
other: mean 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
0.06
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #5, #6
Time point:
other: mean 24, 48, 72h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: mean 24, 48, 72h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
CLINICAL EYE OBSERVATION
-At 1 h p.a. all animals showed slight redness and chemosis of the conjunctivae
-At 24 hours p.a. slight conjunctival redness was still present in 5/6 animals and reversible in 1/6 animals. Chemosis persisted 24 hours p.a. only in 1/6 animals and was reversible in the other 5 animals.
-Cornea and iris were at all scorings without any effects.

Any other information on results incl. tables

Table 4. Individual values of ocular gradings

Animal number

Ocular

 Lesion

Hours after treatment

1

24

48

72

1

Cornea
Iris
Conjunctivae redness
Conjunctivae chemosis

0
0
1
1

0
0
1
0

0
0
0
0

0
0
0
0

2

Cornea
Iris
Conjunctivae redness
Conjunctivae chemosis

0
0
1
1

0
0
1
0

0
0
0
0

0
0
0
0

3

Cornea
Iris
Conjunctivae redness
Conjunctivae chemosis

0
0
2
1

0
0
1
0

0
0
0
0

0
0
0
0

4

Cornea
Iris
Conjunctivae redness
Conjunctivae chemosis

0
0
1
2

0
0
1
1

0
0
0
0

0
0
0
0

5

Cornea
Iris
Conjunctivae redness
Conjunctivae chemosis

0
0
1
1

0
0
1
0

0
0
0
0

0
0
0
0

6

Cornea
Iris
Conjunctivae redness
Conjunctivae chemosis

0
0
1
1

0
0
0
0

0
0
0

0

0
0
0
0

Table 5: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0/0/0/0

0/0/0/0/0/0

1/1/2/1/1/1

1/1/1/2/1/1

24 h

0/0/0/0/0/0

0/0/0/0/0/0

1/1/1/1/1/0

0/0/0/1/0/0

48 h

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

72 h

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

Average 24, 48, 72 h

0/0/0/0/0/0

0/0/0/0/0/0

0.33/0.33/0.33/0.33/0.33/0

0/0/0/0.33/0/0

Average (mean) 24h, 48h, 72h

0

0

0.28

0.06

Area effected

-

-

-

-

Reversibility*)

-

-

c

c

Average time for reversion

-

-

48 h

48 h

*) Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to OECD GHS (2nd rev. edition, UN, 2007) the test item in a 10% (v/v) aqueous solution is classified as non eye irritant.
Executive summary:

In a primary eye irritation study according to OECD Guideline 405, 0.1 mL of a formulation containing 39% act.ingr. in a 10 % (v/v) aqueous solution was instilled into the conjunctival sac of the left eye of six White New Zealand rabbits. The eyes were not rinsed after substance application. Animals then were observed for 72 hours. At 1 h p.a. all animals showed slight redness and chemosis of the conjunctivae. At 24 hours p.a. slight conjunctival redness was still persistent in 5/6 animals and reversible in 1/6 animals. Chemosis persisted 24 hours p.a. only in 1/6 animals and was reversible in the other 5 animals. From 48 - 72 h p.a. no test article-dependent findings were observed. Active ingredient according to producers information: minimum 39 %.; taking this value into account, active ingredient of the test solution was 3.9 % in minimum.