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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:
From 1988-03-15 to 1988-03-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Reliability scoring based on 1987 guideline for test n°405
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Genamin SH 301
IUPAC Name:
Genamin SH 301
Constituent 2
Reference substance name:
Amines, di-C14-18-alkylmethyl
EC Number:
266-923-8
EC Name:
Amines, di-C14-18-alkylmethyl
Cas Number:
67700-99-6
IUPAC Name:
N-hexadecyl-N-methylhexadecan-1-amine
Details on test material:
- Name of test material (as cited in study report): Genamin SH 301
- A statement of identity for Genamin SH 301 was provided on june 2009 by the sponsor Clariant Produkte GmbH (see attached background material). The statement specifies that the following chemical names, CAS registration and EC numbers are appropriate synonyms to describe GENAMIN SH 301:
-> Amines, bis(hydrogentated tallow alkyl)methyl CAS 61788-63-4 EC 262-991-8
-> Amines, di-C14-18-alkylmethyl CAS 67700-99-6 EC 266-923-8
- Physical state: red dark colored cream
- Lot/batch No.: HTWC 255 0000
- Storage condition of test material: At 22 °c, in darkness
- Purity: 100%
- Density: 0.81 kg/l at 50 °C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Konventionelle zucht
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5-2.9 kg
- Diet and water : ad libitum (diet: Altromin 2123)

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70
- Photoperiod : 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: each animal served as its own control
Amount / concentration applied:
- Amount applied :0.1 ml
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
1, 24 48 and 72 hours after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : no

SCORING SYSTEM: according to guideline OECD 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
: 3 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0
Max. score:
0
Remarks on result:
other: All individual scores were 0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
: 3 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Individual mean scores for each animal: 0.7; 1.0 and 0.3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
: 3 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks:
72 hours
Remarks on result:
other: Individual mean scores for each animal: 0.3; 0.7 and 0.0
Irritation parameter:
iris score
Basis:
mean
Remarks:
: 3 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0
Max. score:
0
Remarks on result:
other: All individual scores were 0
Irritant / corrosive response data:
At the 24-hour reading, slight (grade 1) and moderate (grade 2) rednesses of the conjunctivae were observed in 1 and 2 rabbits respectively. A slight chemosis (grade 1) was present in 2 out of 3 rabbits. The redness of the conjunctivae and the chemosis (grade 1) were still present at the 48-hour reading in 1 animal but the recovery was complete at the 72-hour reading time.
No lesions of cornea or iris were reported. (See Table 1 for complete raw data)

Any other information on results incl. tables

Individual scores for eye irritation:

Time after application 1 hr 24 hrs 48 hrs 72 hrs
Rabbit 1 2 3 1 2 3 1 2 3 1 2 3
Scores Chemosis 1 1 1 1 1 0 0 1 0 0 0 0
Conjunctivae 3 1 2 2 2 1 0 1 0 0 0 0
Iris 0 0 0 0 0 0 0 0 0 0 0 0
Cornea opacity 0 0 0 0 0 0 0 0 0 0 0 0

Mean scores calculated for each animal over 24, 48 and 72 hours were (0.3) (0.7) and (0) for chemosis, (0.7) (1) and (0.3) for redness of the conjunctivae, (0) (0) and (0) for iris lesions and (0) (0) and (0) for corneal opacity.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
Conclusions:
Under these experimental conditions, the tested substance Genamin SH 301 is not classified according to CLP (Reg. n° 1272/2008/EC) and directive 67/548/EEC.
Executive summary:

The potential of Genamin SH 301 to induce eye irritation was assessed in 3 rabbits according to the OECD guideline 405 and in compliance with the principles of Good Laboratory Practice regulations.

A single dose of 0.1ml of the test item was instilled into one eye, the other eye was not treated and served as control. The eyes were not rinsed after administration of the test item.

Ocular reactions were observed 1, 24, 48 and 72 hours. The values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were noted for each animal.

Mean scores calculated over 24, 48 and 72 hours for the 3 animals were 0.3 for chemosis, 0.7 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Redness and chemosis were fully reversible within 72 hours.

Under these experimental conditions, Genamin SH 301 was considered non- irritant when administered by ocular route to rabbits.