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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
From May 17, 1984 to Jun. 5, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TK 13110 (CG 21-1201)
- Physical state: Solid
- Lot/batch No.: EP 1
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
- Purity: Pilot sample

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 1920 to 2070 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food NAFAG No.814, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: May 17, 1984 To: May 28, 1984

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test article
Duration of treatment / exposure:
Single dose administration
Observation period (in vivo):
Up to 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
Information not reported.

SCORING SYSTEM: Same scale as the one provided in the OECD guideline 405.

TOOL USED TO ASSESS SCORE: slit lamp

Symptoms - observed daily a.m. and p.m., once daily on weekends and holidays
Body weight - at the beginning of the acclimatization and at the end of test
Mortality - daily a.m. and p.m., once daily on weekends and holidays

The irritating and/or corrosive potential of the test article (theoretical range: nonirritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 hours, and 7 days
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Redness in bulbar and palpebral membranes and chemosis in lids and nictating membranes, all observed in the conjunctiva.
Other effects:
The animals showed a normal body weight development.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to be not irritant to the eyes under the test conditions.