Registration Dossier

Administrative data

Description of key information

SKIN IRRITATION/CORROSION
Based on the weight of evidence approach, the test material was determined to cause severe damage and be highly corrosive to the skin.
EYE IRRITATION
Based on the weight of evidence approach, the test material was determined to cause serious eye damage, and be highly corrosive.
RESPIRATORY IRRITATION
Based on a weight of evidence approach, the test material was determined to cause respiratory irritation.

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:
supporting study
Study period:
Not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study report is presented in an abstract; very little information is available regarding the method of exposure. It is therefore not possible to assess the accuracy of the data.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Irritation and corrosivity observations were performed as part of an aucte dermal toxiicty study. The test material was held in prolonged contact with the skin of a rabbit and the resultant skin reaction was noted.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
The test animal was exposed for 24 hrs.
Irritant / corrosive response data:
Exposure to the test material resulted in moderate to severe chemical burns.
Other effects:
The LD50 of the test material was greater than 1000 mg/kg bw.
Interpretation of results:
highly corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of the study, the test material was shown to cause a severe reaction to the skin, leaving chemical like burns.
Executive summary:

The irritation potential of the test material to the skin was determined in an unspecified species of rabbit. The study records that moderate to severe chemical burns were caused as a result of dermal exposure over a 24 hour period. There is no available information regarding the methods used, so it is not possible to assess the accuracy of the data from the available information.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not reported.
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The data was presented in very limited detail and so it was not possible to assess the accuracy of the data from the information presented.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Various volumes of test material, in water or propylene glycol, were instilled in the eye of rabbits. Eye reactions were observed and graded according to the 10-grade ordinal series based upon the degree of resultant corneal necrosis. The methodology is reported in Smyth et al (1962).
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
other: water or propylene glycol
Controls:
not specified
Amount / concentration applied:
The test material was dosed in a 1% solution in water or propylene glycol. The volume and concentration both varied.
Details on study design:
Scored against a 10-grade ordinal series, bases on the degree of corneal necrosis.

Grade 1 - a very small area of necrosis resulting from 0.5 mL of undiluted chemical
Grade 5 - severe burn from 0.005 mL
Grade 10 - severe burn form 0.5 mL of a 1% solution in water or propylene.
Irritation parameter:
cornea opacity score
Basis:
other: not reported.
Score:
8
Max. score:
10
Remarks on result:
other: No data available for the time point, max. score or reversibility.

No further information on results is reported.

Interpretation of results:
highly corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of the test a strong response was seen in the cornea of the test animals, which permits classification as highly corrosive by expert judgement.
Executive summary:

Various volumes of test material, in water or propylene glycol, were instilled in the eye of rabbits. Eye reactions were observed and graded according to the 10-grade ordinal series based upon the degree of resultant corneal necrosis. Under the conditions of the test a strong response was seen in the cornea of the test animals, which permits classification as highly corrosive by expert judgement.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

SKIN IRRITATION

Three studies and a material safety data sheet have been provided to address this endpoint on a weight of evidence basis.

Smyth (1969) described the test material as being irritating to the skin and was scored 3 on a 10-grade scoring system. The safety data sheet from Alfa Aesar (1975) described the test material as irritating and corrosive to the skin. Pullin (1957) and Fougler (1948) do not provide sufficient information to derive a classification however they support the finding that the test material is irritating and corrosive providing the following observations respectively; severe chemical burns and erythema. All studies have been assigned a reliability score of 4 according to the principles for assessing data quality in Klimisch (1977). The general consensus presented is that the test material is highly irritating and corrosive in the event of contact with the skin and is classified on a worst case basis.

EYE IRRITATION

Two studies and a safety data sheet have been provided to address this endpoint using the weight of evidence approach. Smyth (1969) reports a strong corneal response. Pullin (1975) observed corneal injury, moderate pain, conjunctiva inflammation and slight iritis post exposure. The safety data sheet from Alfa Aesar (1975) described the effects of the test material as an eye irritant and strong corrosive. The general consensus described in the weight of evidence is that the test material is highly irritating and corrosive. All the studies are reported as abstracts and do not mention methods. The reliability of all three sources has been assigned a reliability score of 4, according to the principles for assessing data quality set out in Klimisch (1977). There is sufficient consistency between the sources to act as a weight of evidence, and the consensus is that the test material causes irritation and corrosion when in contact with the eyes.

RESPIRATORY IRRITATION

Respiratory irritation has been observed during acute inhalation toxicity tests; Pullin (1975) and Foulger (1948). Both studies have been

assigned a reliability score of 4, according to the principles for assessing data quality set out in Klimisch (1977).


Justification for selection of skin irritation / corrosion endpoint:
The endpoint was selected since it displayed the most severe skin reaction following exposure to the test material. The study was selected as the worst case scenario.

Justification for selection of eye irritation endpoint:
The endpoint was selected since it displayed the most severe eye reaction following exposure to the test material. The study was selected as the worst case scenario.

Effects on skin irritation/corrosion: highly corrosive

Effects on eye irritation: highly corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

SKIN IRRITATION

The skin irritation studies indicate that the test material is highly irritating and corrosive. A classification under Regulation directive 1272/2008 of "Category 1B, H314: Causes severe skin burns and eye damage”, and signal word “Danger” is taken forward for risk assessment as a worst case basis.

 

EYE IRRITATION

The eye irritation studies indicate that the test material is highly irritating and corrosive. A classification under Regulation 1272/2008 of "Category 1 eye damage, H318: Causes serious eye damage”, and signal word “Danger” is taken forward for risk assessment as a worst case basis..