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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no 1-h reading; 6 animals, thereof 3 rinsed after 30s)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(no 1-h reading; 6 animals, thereof 3 rinsed after 30s)
GLP compliance:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): FAT 66’031/A
- Analytical purity: > 80%
- Physical state: solid (powder)
- Lot/batch No.: Op. 1/81

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS GmbH, Med. Versuchstierzuchten KG, D-7964 Kisslegg.
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet: standard rabbit food (NAFAG, No. 814, Gossau SG); ad libitum
- Water: water; ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required; the other eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
one single exposure
The eyes of 3 animals were rinsed after 30 s; the eyes of the other 3 animals were not rinsed
Observation period (in vivo):
7 days
Reading time points at 24, 48 and 72 h and 4 and 7 days after instillation.
Number of animals or in vitro replicates:
3 per sex
Details on study design:
Only rabbits with normal ophthalmic findings were used in this test.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, the treated eye of 3 rabbits was flushed with 10 mL physiological saline 30 seconds after instillation.

SCORING SYSTEM: Scoring was performed according to the Draize Scoring System.

TOOL USED TO ASSESS SCORE: slit-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed; slight discharge (score = 1) at 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of animal #2 and #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: not rinsed
Irritant / corrosive response data:
Conjunctival redness (grade 2 and 1) developed in 2 animals (not rinsed and rinsed, respectively), and discharge in 1 animal (not rinsed) was observed. These changes were apparent 1 day after instillation, but not thereafter. Only the results of animals that were not rinsed were taken into account for evaluation.
Other effects:
One animal died 7 days after instillation of the test material and it was stated that no symptoms had been observed prior to death.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this experiment the test material was found to cause a minimal irritation when applied to the rabbit eye mucosa.