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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Vulkacit I is not irritation to the skin and eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: reported in brief but sufficient information for assessment
Principles of method if other than guideline:
500 mg of the testsubstance were applied to the inner surface of one ear of each of 2 New Zealand White rabbits held in place by plaster for 24 hours. After termination of the exposure the ear was cleaned with water, soap and oil and the animals were observed for further 7 days
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
body weight at study inititiation: 3-4 kg
male and female
housing: individually
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: the other ear (inner surface)
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
500 mg of the testsubstance were applied to the inner surface of one ear of each of 2 New Zealand White rabbits held in place by plaster for 24 hours. After termination of the exposure the ear was cleaned with water, soap and oil and the animals were observed for further 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: at the end of the observation period
Score:
ca. 0
Reversibility:
other: the substance caused no irritation
Irritant / corrosive response data:
the substance caused no irritation
Other effects:
no data
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

500 mg of the testsubstance were applied to the inner surface of one ear of each of 2 New Zealand White rabbits and held in place by plaster for 24 hours. After termination of the exposure the ear was cleaned with water, soap and oil and the animals were observed for further 7 days. Vulcacit I caused no irritation (Mihail 1977).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reporting in brief but sufficient information for assessment
Principles of method if other than guideline:
Single application of 50 mg testsubstance into the conjunctival sac of one eye of each of 2 rabbits; observation time: 7 days
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
body weight at study initiation: 3-4 kg
male and female
housing individually
Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye of each of the 2 rabbits
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
no data specified
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
Single application of 50 mg testsubstance into the conjunctival sac of one eye of each of 2 rabbits; observation time: 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: at the end of the 7 day observation period
Score:
ca. 0
Reversibility:
other: the substance caused no irritation
Irritant / corrosive response data:
the substance caused no irritation
Other effects:
no data
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Single application of 50 mg testsubstance into the conjunctival sac of one eye of each of 2 rabbits; observation time: 7 days.

Vulcacit I caused no irritation (Mihail 1977)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

SKIN IRRITATION / CORROSION

500 mg of the testsubstance were applied to the inner surface of one ear of each of 2 New Zealand White rabbits and held in place by plaster for 24 hours. After termination of the exposure the ear was cleaned with water, soap and oil and the animals were observed for further 7 days. Vulcacit I caused no irritation

EYE IRRITATION

Single application of 50 mg testsubstance into the conjunctival sac of one eye of each of 2 rabbits; observation time: 7 days.

Vulcacit I caused no irritation (Mihail 1977)


Justification for selection of skin irritation / corrosion endpoint:
the only available study which is reported in brief but providing sufficient information to be considered for assessment

Justification for selection of eye irritation endpoint:
the only available study which is reported in brief but providing sufficient information to be considered for assessment

Justification for classification or non-classification

Based on the available data no classification or labelling is required.