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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:
06/11/2006 - 14/12/2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD Guidelines for Testing of Chemicals, Section 4, Health Effects, No 405, 'Acute Eye Irritation / Corrosion", Paris Cedex, 2002
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
European Community (EC), Council Directive 67/548/EEC, Annex V, Part B, Methods for the Determination of Toxicity, as last amended by Commission Directive 2004/73/EC, B.5: "Acute Toxicity: Eye irritation / corrosion", 2004
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870,2400, Acute Eye Irritation. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-98-195, August 1998
Qualifier:
according to
Guideline:
other: JMAFF Notification No 8147
Version / remarks:
Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder
Details on test material:
- Description: dark purple powder
- Solubility in the water: <= 0.412 g/L
- Melting point: > 250 °C
- Boiling point: > 250 °C
- Explosion: not explosion
- Log Pow: >= 3.3
- Test substance storage: at room temperature in the dark, 20°C, dry store
- Stability under storage conditions: stable
Specific details on test material used for the study:
pH (1% in water, indicative range): 8.1-8.3 (determined at NOTOX)
Stability at higher temperatures: maximum temperature 75°C, maximum duration 48 hours

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Harlan, Horst, The Netherlands
Number of animals: 3 males
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: ear mark
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

Test system

Amount / concentration applied:
Single samples of approximately 41 mg of SXJUL2006 (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits.
Observation period (in vivo):
Observations were made 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 5 weeks later, after considering the degree of eye irritation observed in the first animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Irritation
Remarks on result:
other: No iridial or corneal opacity were observed, and treatment of the eyes with 2% fluorescin, 24 hours after test substance instillation revealed no corneal epithelial damage.
Irritation parameter:
other: Corrosion
Remarks on result:
other: There was no evidence of ocular corrosion
Irritation parameter:
other: Colouration/Remnants
Remarks on result:
other: Remnants of the test substance were present on the outside of the eyelids between days 1 and 3. Purple staining of the fur on the head and paws was noted during observation period. No staining of (peri) ocular tissues by the test substance was observed.
Irritation parameter:
other: Toxicity / Mortality
Remarks on result:
other: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results SXJUL2006 does not have to be classified and has no obligatory labelling requirement for eye irritation according to Globally Harmonized System of Classification and Labelling of Chemical (GHS) of the United Nations (New York and Geneva, 2003) and EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC)