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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:
23.04.2008-24.04.2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
see below
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
see below
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
yes
Remarks:
see below
Qualifier:
according to guideline
Guideline:
other: JMAFF guidelines (2000) including the most recent partial revisions
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
The body weight of the animal was not determined after sacrifice.
Evaluation: Sufficient data was available to assess the possible irritation or corrosion potential of the test substance.

The study integrity was not adversely affected by the deviations.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
EC Number:
271-756-9
EC Name:
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
Cas Number:
68607-24-9
Molecular formula:
The substance is a quarternary ammonium chloride derived from fatty alcohol. The general chemical structure is R-N(Me)3+ Cl-, whereas the alkylrest R is variable for the main components C20 and C22 but also shorter and longer C-Chains (in smaller amounts)
IUPAC Name:
N,N,N-trimethyl-C20-22-(even numbered)-alkyl-1-aminium chloride
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 10-12 weeks old
- Weight at study initiation: 2215 g
- Housing: Individually in labeled cages with perforated floors (dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3 – 21.3
- Humidity (%): 45 - 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 64.9 mg (volume of approx. 0.1ml)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1 and 24 hours after instillation of the test substance
Number of animals or in vitro replicates:
1male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 24 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 24 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 24 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
chemosis score
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritant / corrosive response data:
Instillation of approximately 65 mg of the test substance (a volume of approximately 0.1 mL) into an eye of one rabbit resulted in effects on the cornea, iris and conjunctivae.
The corneal injury consisted of opacity (maximum grade 2) and epithelial damage (100% of the corneal area). Iridial irritation grade 1 was observed and the irritation of the conjunctivae consisted of redness, chemosis and discharge.
Grey/white discoloration of the eyelids and nictating membrane (a sign of necrosis) was noted. Erythema and oedema of the outside of the eyelids was noted.
Based on the severity of the ocular lesions observed during the study, the animal was sacrificed for ethical reasons immediately after the 24 hours observation and the two further rabbits assigned to the study were not treated.
Other effects:
Remnants of the test substance were present in the eye on Day 1.
No staining of (peri) ocular tissues by the test substance was observed.
No symptoms of systemic toxicity were observed in the animal until the animal was sacrficed due to severe ocular effects.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The eye irritation/corrosion of the registration substance was investigated according to the guideline OECD 405. Signs of severe ocular lesions were found within 24hours after the single treatment of an eye of one rabbit. The registration substance is to be classified as having irreversible effects on the eye, Cat 1.

Executive summary:

The eye irritation/corrosion of the registration substance was investigated according to the guideline OECD 405. A sample of 65 mg of the registration substance moistured with water (a volume of 0.1 ml) was applied into an eye of one rabbit. Within 24 hours signs of severe ocular lesions was noted. (discoloration of the eyelied, nictating membrane, changes of the outside of the eyelieds). For the ethical reasons the animal was sacrified and the two further rabbits assigned to the study were not treated. The registration substance is to be classified as having irreversible effects on the eye, Cat 1.