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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 28, 1990 - September 7, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study (OECD)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
GLP compliance:
yes
Remarks:
Experimental Toxicology CIBA-GEIGY Limited 4332 Stein / Switzerland

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
EC Number:
407-000-3
EC Name:
A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
Cas Number:
127519-17-9
Molecular formula:
C27 H37 N3 O3
IUPAC Name:
heptyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; nonyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; octyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate
Details on test material:
- Physical state: liquid, viscouse
- Analytical purity: 98%
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: approx. 9 - 13 weeks
- Weight at study initiation: 2290 to 2560 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
single instillation, not washed
Observation period (in vivo):
1, 24, 48, 72 hours and 10 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: OECD scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Instillation of the test substance caused minimal corneal irritation in 2/3 animals at the 1-hour timepoint, reversible within 24 hours. Conjunctival effects were redness and chemosis in all three animals; chemosis was reversible after 24 hours and redness after 10 days.
Other effects:
No other effects.

Any other information on results incl. tables

Individual Irriation Scores:

        Conjunctiva
    Cornea Iris Redness Chemosis
1 h 245 1 0 2 1
799 1 0 2 1
895 0 0 2 1
24 h 245 0 0 1 0
799 0 0 1 0
895 0 0 1 0
48 h 245 0 0 1 0
799 0 0 1 0
895 0 0 1 0
72 h 245 0 0 1 0
799 0 0 1 0
895 0 0 1 0
mean 24 - 72 h 245 0.0 0.0 1.0 0.0
799 0.0 0.0 1.0 0.0
895 0.0 0.0 1.0 0.0
mean 24 - 72 h 0.0 0.0 1.0 0.0
7 days 245 0 0 0 0
799 0 0 1 0
895 0 0 1 0
10 days 245 0 0 0 0
799 0 0 0 0
895 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions employed the test article induced mild irritation of the cornea and conjunctiva below the threshold of signifcance and is therefore regarded as not irritating to the rabbit eye.
Executive summary:

In a GLP-compliant eye irritation study performed according to OECD guideline 405, three New Zealand White rabbits were treated with 0.1 ml of the test article. The test article was placed into the conjunctival sac of the left eye of each animal; the lids were then held together for about one second in order to prevent loss of the test material. The right eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation and animals were checked daily for signs of systemic toxicity. Because reactions were observed within 72 hours after instillation of the test article, the observation period was extended to 10 days. Instillation of the test substance caused minimal corneal irritation in 2/3 animals at the 1-hour time point, reversible within 24 hours. Conjunctival effects were redness and chemosis in all three animals; chemosis was reversible after 24 hours and redness after 10 days. Since the observed ocular effects were below the threshold of significance, the test article is classified as not irritating.