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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:
June/July 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study but information on purity and composition of the test substance is not given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
the eyes of three/six animals were rinsed 4 seconds p.a.
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
EEC directive 84/449/EEC, September 19, 1984
Deviations:
yes
Remarks:
the eyes of three/six animals were rinsed 4 seconds p.a.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
EC Number:
930-947-3
IUPAC Name:
Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever; Kaninchenfarm D-2740 Bremervörde
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individual housing (cage size: 40 cm high, 45 cm wide, 50 cm long) in a battery of cages, each equipped with a paper roll disposal system
- Diet: ad libitum, standard laboratory rabbit diet Ssniff Mü Z
- Water: ad libitum, aqua fontana as for human consumption
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50 - 85
- Air changes (per hr): no data
- Photoperiod: fluorescent light (120 lux) 12 hours daily from 7.00 a.m. - 7.00 p.m

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Each animal served as its one control. The test article was introduced into the conjunctival sac of one eye, the untreated eye serving as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
- Concentration: undiluted
- Preparation of the test substance: The test substance was applied fine ground.
Duration of treatment / exposure:
Eyes of 3 animals were rinsed 4 seconds p.a., the eyes of the other tree animals were not rinsed after treatment.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- On animal 4- 6 the treated eye was washed out 4 sec. p.a. with 10 mL lukewarm water.
-- Time after start of exposure: 4 seconds

SCORING SYSTEM: Draize Scheme as stipulated by OECD 405

TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1 h, 24 h, 48 h, 72 h after treatment. Besides the eyes were examined for potential eye lesions 24 h and 72 h p.a. by means of 1 % fluorescein-dilution(1 drop/eye).
It was washed out about 60 sec. p.a. with sterile, non-pyrogenic, physiol. saline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #4; #5; #6
Time point:
other: mean 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: eyes rinsed
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: mean 24, 48, 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: eyes rinsed
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: mean 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: eyes rinsed
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 hours
Score:
1.33
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: eyes rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 hours
Score:
2.67
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: eyes rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: mean 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: eyes rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean 24, 48, 72 hours
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: eyes rinsed
Irritation parameter:
chemosis score
Basis:
animal: #4, #5
Time point:
other: mean 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: eyes rinsed
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: mean 24, 48, 72 hours
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: eyes rinsed
Irritant / corrosive response data:
CLINICAL EYE OBSERVATION
- In unrinsed eyes severe eye reactions were seen at the 60 minutes and the 24 hour scoring:
-- Cornea scores of 0 or 1
-- Iris scores of 1 or 2
-- Conjunctivae redness scores of 2 or 3
-- Conjunctivae chemosis scores of 3 or 4
Due to the severe reactions these animals were killed after the 24 hour scoring.

In eyes rinsed 4 seconds p.a. the test substance was irritating.
-- Cornea scores of 0
-- Iris scores of 0 or 1
-- Conjunctivae redness scores of 2 or 3
-- Conjunctivae chemosis scores of 2 or 3

REVERSIBILITY: The observation time did not extend beyond 72 hours, even though severe eye responses were still present at these times, therefore, the reversibility of the eye effects cannot be evaluated.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0/0/0/0

0/0/2/1/1/1 

 2/2/3//2/2/3

3/3/3/3/2/2

24 h

1/0/1/0/0/0

 2/0/2/2/1/1

3/2/3/3/2/3 

 4/4/4/2/2/3

48 h

*/*/*/0/0/0

 */*/*/1/1/0

 */*/*/3/2/3

 */*7*/2/2/3 

72 h

 */*/*/0/0/0

 */*/*/1/1/0

  */*/*/2/2/3 

 */*/*/2/2/2 

Average 24h, 48h, 72h

not calculated

 not calculated

not calculated 

 not calculated

Area effected

 no data

 no data

 no data

 no data

Maximum average score (including area affected, max 110)

 no data

 no data

 no data

 no data

The eyes of animal 1 to 3 were unwashed, the eye of animal 4 to 6 were rinsed 4 seconds p.a

* = Due to the severe reactions these animals were killed after the 24h value

The observation time did not extend beyond 72 hours, even though severe eye responses were still present at these times, therefore, the reversibility of the eye effects cannot be evaluated.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Interpretation is based on effects on the corneal opacity/iritis and conjunctival redness/chemosis calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material in the rinsed eyes. The scores for corneal opacity are 0, for iritis are >= 1 and for conjunctival redness/chemosis >= 2. The observation time did not extend beyond 72 hours, even though severe eye responses were still present at these times, therefore, the reversibility of the eye effects cannot be evaluated.
Whereas an evaluation of the unwashed eyes was not possible because they were all killed 24 h p.a. due to the severe eye reactions.
The test substance Fettsäuredimethylaminopropylamid was judged to be irritating to the eye bases on the effects in the rinsed eye within 72 hours. An evaluation of the unwashed eyes was not possible.
Executive summary:

In a primary eye irritation study according to OECD Guideline 405 and EU Method B.5, 0.1 g of Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl] was instilled into the conjunctival sac of six White New Zealand rabbits. The eyes of three animals were rinsed 4 seconds after substance application. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 405.

In unrinsed eyes severe eye reactions were seen at the 60 minutes and the 24 hour scoring:

-- Cornea scores of 0 or 1

-- Iris scores of 1 or 2

-- Conjunctivae redness scores of 2 or 3

-- Conjunctivae chemosis scores of 3 or 4.

Due to the severe reactions these animals were killed after the 24 hour scoring.

In eyes rinsed 4 seconds p.a. the test substance induced

-- Cornea scores of 0

-- Iris scores of 0 or 1

-- Conjunctivae redness scores of 2 or 3

-- Conjunctivae chemosis scores of 2 or 3

The observation time did not extend beyond 72 hours, even though severe eye responses were still present at these times, therefore, the reversibility of the eye effects cannot be evaluated.

The test substance was judged to be irritating to the eye based on the effects of the rinsed eye (washed out 4 secondes p.a.) within 72 hours.

Whereas an evaluation of the animals with unwashed eyes was not possible because they were killed 24 h p.a. due to the severe eye reactions.