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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From November 15 to 22, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Source study has reliability 1. Details on the read across are available in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.2 kg
- Housing: one rabbit per cage (Drahtkäfige Typ III - hoch)
- Pellet: Holzgranulat Typ S 8/15 (Firma Sniff, Soest)
- Diet: ca. 100 - 120 g per animal per day of Sniff K 4 (Sniff Spezialdiäten GmbH, Soest/Westfallen)
- Water: ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: ca. 50%
- Air changes: ca. 10 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours (ca. 27 Watt/m2)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- pH: 0.5
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
1 female rabbit
Details on study design:
APPLICATION:
After the application of the test substance, the lids were held together for about 1 second

REMOVAL OF TEST SUBSTANCE
- Washing: with saline solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize grade

TOOL USED TO ASSESS SCORE: in order to analyse cornea and iris, optical device and fluorecina (1 %)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: T52
Time point:
other: mean score (24, 48, 72 h)
Score:
ca. 2.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Remarks:
area
Basis:
animal: T52
Time point:
other: mean score (24, 48, 72 h)
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal: T52
Time point:
other: mean score (24, 48, 72 h)
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal: T52
Time point:
other: mean score (24, 48, 72 h)
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible

Any other information on results incl. tables

animal no. weight sex target symptome 1 h 24 h 48 h 72 h 7 d 14 d
T52 3.2 kg F cornea T X 2 3 3 - -
F X 4 4 4 - -
fluorescein I - 2 3 3 - -
F - 4 4 4 - -
iris X 2 2 2 - -
conjunctivae R X 3 3 3 - -
S 4 3 3 3 - -

humor

aquosus

X nb nb nb - -
lacrimation 2 2 2 2 - -

T = opacity,  F = area,  I = intensity,  R = redness,  S = swelling,  X = impossible to judge,  nb = impossible to judge for opacity,  - = not applicable

Applicant's summary and conclusion

Interpretation of results:
other: cat. 1 causes serious eye damage, according to the CLP Regulation (EC 1272/2008)
Conclusions:
The substance causes serious eye damage.
Executive summary:

Method

The substance was tested for eye damage according to OECD guideline 405, using one albino rabbit, as recommended in the guideline.

Results

The observed effects were not reversible by 72 hours. Test substance caused seriuos eye damage.