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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:
2008-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF, 12 Nousan, Notification No 8147
Version / remarks:
November 2000, including the most recent partial revisions
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
SPF-Quality
Details on test animals or tissues and environmental conditions:
Test animals source: Harlan France SARL, Gannat, France.
Age and body weight Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.
Identification: Earmark.
Health inspection A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.

Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +- 3.0°C (actual range: 22.2 - 22.7°C), a relative humidity of 30 - 70% (actual range: 42 — 63%) and 12 hours artificial fluorescent light and 12 hours darkness per day.

Accommodation
Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.

Diet
Pelleted diet for rabbits (K-H from SSNIFF® Spezialdiaten GmbH, Soest, Germany) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.

Water
Free access to tap water.

Results of analysis for each batch of diet (nutrients and contaminants), hay and water were assessed and did not reveal any findings that were considered to have affected the study
integrity. All certificates and results of analysis are retained in the NOTOX archives.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Animals were treated by instillation of, on average, 33.3 mg (range 33.1 — 33.5 mg) of the test substance (a volume of approximately 0.1 mL) in the conjunctival sac of one of the eyes after
gently pulling the lower lid away from the eyeball.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3
Details on study design:
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 1 week later, after
considering the degree of eye irritation observed in the first animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
24 hours
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
24h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
24h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
72h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
0
Reversibility:
fully reversible within:
Remarks:
48h
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
48h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
24h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
72h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48h
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
not fully reversible within:
Remarks:
48h
Other effects:
No staining of (peri) ocular tissues by the test substance was observed. Remnants of the test substance were present in the eye of two animals on Day 1.
Blue staining of the fur on the head and paws, caused by the staining properties of the test substance, was noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results SULFOBUTYL TMBI does not have to be classified and has no obligatory labeling requirement for eye irritation according to the:
- Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nafions(2007L
- Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures,
- EC criteria for classification and labeling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this Directive published in the Official Journal of the European Communities).