Registration Dossier

Administrative data

Description of key information

SKIN IRRITATION/CORROSION
Non-corrosive; in vitro; Corrositex® test method
Not irritating; rabbit; Code of Federal Regulations, Title 16, Section 1500, 41
EYE IRRITATION
Not irritating; rabbit; Code of Federal Regulations, Title 16, Section 1500, 42

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Remarks:
in vitro
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The information is provided from a reliable secondary source.
Qualifier:
according to
Guideline:
other: Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
- the original study was conducted in 1975
Species:
rabbit
Strain:
other: Albino
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No data
Duration of treatment / exposure:
No data
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0.05
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test material is non-irritating to the eye.
Executive summary:

The eye irritation potential of the test material was investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42. These methods are similar to those outlined in the standardised guideline OECD 405.

Six Albino rabbits were exposed to the test material and observed for 7 days. Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days.

Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.

Under the conditions of this study, the test material is non-irritating to the eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/Corrosion

This endpoint is addressed on a weight of evidence basis using an in vitro corrosion test and an in vivo irritation test conducted on a read across substance.

The test material was analysed by the in vitro Corrositex method to determine its corrosive potential and Packing Group designation.

The Corrositex test is a standardised and reproducible method that can be employed to determine the potential corrosivity and determine the Packing Group classification of specified categories of chemical compounds under the hazardous materials transportation regulations administered by the U.S. Department of Transportation (DOT) and international dangerous goods codes. The Corrositex test predicts the in vivo corrosive potential of a chemical compound or mixture by using as an endpoint the time it takes for the chemical to permeate through or destroy a synthetic biobarrier. When the chemical has passed through this biobarrier, a visual change is produced in a proprietary Chemical Detection System (CDS).

The Corrositex test is performed in three steps. First, a qualification test is done to ensure that the test material and the CDS reagent are compatible. The second step utilises appropriate indicator solutions to permit categorisation of the test material as either a Category 1 or Category 2 material. The third step is performed by applying the test sample to the biobarrier. When the chemical permeates through or destroys the full thickness of this biobarrier, it comes into contact with the CDS which then undergoes a simple colour change. This colour change is visually observed and the time required for the colour change to occur is recorded. The time required to destroy the biobarrier is recorded for four sample replicates and the mean of these replicates is utilised to designate the UN Packing Group classification.

The results indicated that the test material was compatible with the Corrositex system and was classified as Category 2 material. The results obtained from the evaluation of four replicate samples were highly reproducible. The test material demonstrated a mean time of >60 minutes required to destroy the synthetic biobarriers.

Under the conditions of this study, the test material was found to be non-corrosive. 

The skin irritation potential of Sanolin Blue EHRLwas investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 41.

The test material in distilled water was applied to the intact and abraded skin of Albino rabbits and the skin irritation assessed using a patch test technique that was carried out in an occlusive fashion. Animals were observed for 72 hours.

Evaluation of skin reactions (scores) was not provided. The summary report states that no animals showed any observable response to treatment throughout the 72 hour observation period.

Under the conditions of this study, the test material is non-irritating to skin.

Eye Irritation

The eye irritation potential of Sanolin Blue EHRL was investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42. Six Albino rabbits were exposed to the test material and observed for 7 days. Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days. Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.

Under the conditions of this study, the test material is non-irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
This endpoint is addressed on a weight of evidence basis. Therefore no single study is selected as key.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to either skin or eye irritation.

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to either skin or eye irritation.