Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
Test according to OECD guideline 405 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-07-25 to 1990-08-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test according to OECD guideline 405 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990, but lack of data on the purity / quality of the sample tested.
Remarks:
Test according to OECD guideline 405 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990, but lack of data on the purity / quality of the sample tested.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Hydroxyambran

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals:
Species: rabbit
Strain: White New Zealands
Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde, Neuendamm 88
Date of receipt July 17, 1990
Acclimation period: at least 7 days
Animal selection: random
Animal identification: with individual earmarks; cage labelled with the following information: earmark, sex, date of study initiation, IBR project no.
Weight range at
study initiation: 2.4 - 2.8 kg

Husbandry:
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.
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 18 +/- 2 °C
Relative humidity: 50 – 85 %
Measurement: with thermohygrometer twice daily
Diet: Administration: ad libitum
Manufacturer: Ssniff Spezialdiäten GmbH, 4770 Soest Westfahlen
Name: Ssniff-MÜ Z (Alleindiät für Zuchtkaninchen)
Form: Pellets
Water: Administration: ad libitum
System: drinking nipples
Quality: drinking water as for human consumption
Quality control: analytical and bacteriological controls every six months

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml (not more than 100 mg) into the conjunctival sac of the left eye.
Duration of treatment / exposure:
A removing of the test article from the eyes is not prescribed in the test report.
An exposure duration can not be stated therefore.
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3
Details on study design:
Preparation of the Animals:
Prior to test initiation, all animals were acclimated to laboratory conditions for at least 7 days. 24 h before treatment, the eyes of all animals were examined for potential eye lesions with an ophthalmoscope and healthy animals were subsequently earmarked for individual identification.

Preparation of the Test Article:
The test article was applied undiluted.

Procedure:
In each animal, 0.1 ml (not more than 100 mg) of the test article was introduced into the conjunctival sac of the left eye, while the right eye was used as a control.

Observations:
Using an ophthalmoscope, ocular reactions were assessed 1, 24, 48 and 72 h after treatment. Extended observation until day 7 was necessary to determine reversibility or irreversibility of the lesions observed.
Dermal irritation was evaluated according to a same scheme as presented in the REGULATION (EC) No 44/2008, B.5.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #1
Time point:
other: Cornea
Score:
0
Max. score:
0
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #1
Time point:
other: Iris
Score:
0
Max. score:
0
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #1
Time point:
other: Conjunctivae, reddness
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 5 d
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #1
Time point:
other: Conjuctivae chemosis
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 d
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #2
Time point:
other: Cornea
Score:
0
Max. score:
0
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #2
Time point:
other: Iris
Score:
0
Max. score:
0
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #2
Time point:
other: Conjuctivae, redness
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #2
Time point:
other: Conjunctivae, chemosis
Score:
0
Max. score:
0
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #3
Time point:
other: Cornea
Score:
0
Max. score:
0
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #3
Time point:
other: Iris
Score:
0
Max. score:
0
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #3
Time point:
other: Conjuctivae, redness
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 6 d
Irritation parameter:
other: Mean values of ocular gradings over the time points 24, 48 and 72 h
Basis:
animal #3
Time point:
other: Conjuctivae, chemosis
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 5 d
Irritant / corrosive response data:
Individual values of ocular gradings
Animal Ocular Hours after treatment Days after treatment
number lesion 1 24 48 72 4 5 6
1 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjunctivae, redness 1 2 2 2 1 0 0
Conjunctivae, chemosis 1 1 1 1 0 0 0
2 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjunctivae, redness 1 1 0 0 0 0 0
Conjunctivae, chemosis 0 0 0 0 0 0 0
3 Cornea 0 0 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjunctivae, redness 2 2 2 2 1 1 0
Conjunctivae, chemosis 1 2 2 2 1 0 0

Any other information on results incl. tables

The observed findings were reversible within 48 hours - 6 days p.a.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article "Hydroxyambran" is to classify as "irritant to eyes" with reversible action.
Executive summary:

The acute eye iritation/corrosion of Hydroxyambran was determined according to the OECD Test Guideline 405 in rabbits.

In 2 of 3 animals a mean score of 2.0 for conjunctivae, redness with full reversibitity within 6 days was observed.

According to the classification system in the REGULATION (EU) 1272/2008 is the test article "Hydroxyambran" to classify as "irritant" with reversible action.