Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-04 till 2008-06-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline-conform study under GLP without deviations

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Molecular formula (if other than submission substance): C21H41NO4S.Na
- Smiles notation: CCCCCCCCC=CCCCCCCCC(=O)N(C)CCS(=O)(=O)O[Na]
- Physical state: solid
- Stability under test conditions: stable at room temperature (range of 20 ± 5 °C), light protected.
- Storage condition of test material: Room temperature, light protected

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 15 weeks (male), 15-16 weeks (females)
- Weight at study initiation: 2628 g (male), 2480 and 2803 (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum
- Acclimation period: 04-JUN-2008 to 08-JUN-2008 (one female), 04-JUN-2008 to 15-JUN -2008 (one male and one female)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours/ 12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: control area on same animal (right eye)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per animal

Duration of treatment / exposure:
72 hrs
Observation period (in vivo):
up 7 days in the male and one female and up to 14 days in the first treated female after test item instillation.
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.
Scleral reddening and ocular discharge were also assessed.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs; 7, 10 and 14 days
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs; 7, 10 and 14 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs; 7, 10 and 14 days
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs; 7, 10 and 14 days
Score:
1.67 - 2
Max. score:
2
Reversibility:
fully reversible within: 48 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification (Commission Directive 2001/59/EC of August 06, 2001), Hostapon TPHC is considered to be “not irritating” to the rabbit eye.
Executive summary:

The primary eye irritation potential of the registration substance was evaluated in the New Zealand albino rabbit according to OECD test guideline 405. Only animals without ocular abnormalities were used for the study. o.1 mL of undiluted test material was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. The instillation of the test material into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as corneal opacity, reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment. The individual mean scores for corneal opacity was 0.67 for all three animals. The individual mean scores for the conjunctivae were 2.00 for reddening and 0.67, 0.33 and 0.67 for chemosis for each of the three animals. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. White test item remnants were evident in the eye or conjunctival sac of one female 1 hour after instillation. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Based on the findings and in accordance with the classification criteria of Directive 67/548 EEC (DSD), the registration substance is considered to be "not irritating" to the rabbit eye. However, based on the criteria of Directive (EC) 1272/2008 (GHS-CLP) the registration substance should be considered to be "mildly irritating to eyes" (category 2B).