Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15.01.2008 to 24.08.2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study report

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species: Albino rabbit, New Zealand White (SPF-Quality) Recognized by international guidelines as the recommended test system (e.g. EC, OECD)
Source: Harlan France SARL, Gannat, France.
Number of animals: 1 Male
Age and body weight: The animal used within the study was at least 6 weeks old and its body weight was at least 1.0 kg.
Identification: Earmark.
Health inspection: A health inspection was performed prior to commencement of treatment, to ensure that the animal was in a good state of health.
Special attention was paid to the eyes, which were free from any abnormality.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A single sample of approximately 68 mg of DCM (a volume of approximately 0.1 ml) was instilled into an eye of one rabbit
Observation period (in vivo):
Observations were made 1 hour after instillation
Number of animals or in vitro replicates:
1 Male
Details on study design:
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). Based on signs of toxicity observed
during the study, the animal was sacrificed for ethical reasons immediately after the 1 hour observation and the two further rabbits assigned to
the studywere not treated.

Results and discussion

Any other information on results incl. tables

Based on signs of toxicity (ventro-lateral recumbency, hypotonia and lethargy), the animal was sacrificed for ethical reasons immediately after the 1 hour observation and the two further rabbits assigned to the study were not treated. The signs of toxicity described above show that the substance is also absorbed via the eye.

Applicant's summary and conclusion

Interpretation of results:
other: Due to secondary toxicity DCM could not be classified regarding eye irritation.
Remarks:
Criteria used for interpretation of results: other: Due to secondary toxicity DCM could not be classified regarding eye irritation.
Conclusions:
Based on signs of toxicity observed during the study, the sentinel animal was sacrificed for ethical reasons immediately after the 1 hour
observation and the two further rabbits assigned to the study were not treated. At the 1 hour observation, irritation of the cornea, iris and
conjunctivae was observed, but no corrosion was visible in the treated animal. Therefore, the nature and reversibility of the effects on the
eye could not be determined.
In conclusion, insufficient data is available to assess the irritation or corrosion potential of DCM.
Based on these results, DCM could not be classified and no obligatory labelling requirement could be determined for eye irritation according to theGlobally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004) and EC criteria for classification
and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).