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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:
18 Aug - 08 Sep 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
02 Oct 2012
Deviations:
yes
Remarks:
(no systemic analgesic and topical anesthesia used)
GLP compliance:
yes (incl. certificate)
Remarks:
Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
HdIf:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: > 2.0 kg weight
- Housing: housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
Animal no.1: 20 days; Reading time points: 1, 24, 48 and 72 h and daily from Day 4 - Day 20
Animal no. 2 and 3: 168 h; Reading time points: 1, 24, 48 and 72 h and daily from Day 4 - Day 7
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
1.2
Max. score:
3
Reversibility:
fully reversible within: 7 days in 2 animals, within 4 days in 1 animal
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: within 3 days in 1 animal, within 2 days in 2 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
not fully reversible within: 20 days in 1 animal, no effect in 2 animals
Irritant / corrosive response data:
Instillation of the test substance into the eyes of rabbits produced signs of irritation in all animals. In detail, redness and chemosis of the conjunctivae were observed in all test animals. Those effcets were fully reversible latest within 168 or 72 hours, respectively. Furthermore, 1/3 animals showed corneal opacity which was not reversible until the end of the observation period (20 days). In the 2 remaining animals, no effects on the cornea were determined. No effects on the iris were observed in any test animal.
Other effects:
Body weight evolution appeared normal.

Any other information on results incl. tables

Table 1 Results of eye irritation

Rabbit # Time [h] conjunctivae   iris cornea
redness swelling
1 1 2 2 0 1
24 1 1 0 1
48 1 0 0 1
72 1 0 0 1
average 1,0 0,3 0,0 1,0
2 1 2 2 0 0
24 2 1 0 0
48 1 0 0 0
72 1 0 0 0
average 1,3 0,3 0,0 0,0
3 1 2 2 0 0
24 2 1 0 0
48 1 1 0 0
72 1 0 0 0
average 1,3 0,7 0,0 0,0
   
Time [h] conjunctivae   iris cornea
  redness swelling    
average
score
1 2,00 2,00 0,00 0,33
24 1,67 1,00 0,00 0,33
48 1,00 0,33 0,00 0,33
72 1,00 0,00 0,00 0,33
24+48+72 1,2 0,4 0,0 0,3

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
CLP: Cat. 1, H318