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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study with acceptable restrictions

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:
yes
Remarks:
- purity of test substance not specified
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
EC Number:
295-714-4
EC Name:
Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
Cas Number:
92128-22-8
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Reaction products of tall-oil fatty acids and (3-aminopropyl)dimethylamine
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: Hacking & Churchill Ltd. (Huntingdon, U.K.)
- Age at study initiation: not specified
- Weight at study initiation: 3.7 - 3.9 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye (untreated) of each animal served as control
Amount / concentration applied:
Amount applied: 0.1 ml (undiluted)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours and 7, 14, 21 days after the 24-hr exposure period
Number of animals or in vitro replicates:
3 (males)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated eye was rinsed with saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to DRAIZE


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

All animals showed distinct large-area corneal opacity and moderate to high irritation effects at the conjunctivae as well as short-term slight iritis in two animals. Within the 21-day post-observation period restitution with normal eye findings were observed.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Executive summary:

In an eye irritation test the test substance was highly irritating to the eyes of rabbits according to OECD TG 405. Within the 21-day post-observation period restitution with normal eye findings were observed.