Registration Dossier

Administrative data

Description of key information

Key studies were performed according to internationally recognised testing guidelines prior to the adoption of the OECD Principles of GLP in 1992.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Remarks:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
not specified
GLP compliance:
no
Remarks:
The study was conducted in the USA in 1981, before the adoption of the OECD Principles of GLP in 1992.
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: two test sites per animal. Skin on one test site was abraded, and was left intact on the other test site.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
Six (6) New Zealand white rabbits each received a single dermal application of 0.5 milliliter of the test article on two test sites, one abraded and one intact. The test sites were occluded for 214 hours and were observed individually for erythema, edema, and other effects 24 and 72 hours after application. Mean scores from the 214 and 72 hour. readings were averaged to determine the primary irritation index. The test article was used as received.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
1.48
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
This test article is not a primary dermal irritant to rabbits under conditions of this test.
Interpretation of results:
GHS criteria not met
Conclusions:
The primary dermal irritation index score was determined to be 1.48 after 72 hours unde the conditions of the test.
Executive summary:

In this guideline equivalent study ( EPA OPP 81 -5) and prior to the adoption of OECD principles of GLP, the test material (EC 205-363-0) induced a primary dermal irritation score of 1.48. The study was conducted in 6 New Zealand White rabbits across the 24, 48, & 72 hour observation periods. The test material was exposed to the test animals (intact skin and abbraded skin, 24 hours) under occlusive conditions. The result of the test is not sufficient to meet the criteria for classification as a skin irritant under the criteria of the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
not specified
GLP compliance:
no
Remarks:
The study was conducted in the USA in 1981, before the adoption of the OECD Principles of GLP in 1992.
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Details on study design:
Six (6) New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 milliliter of the test article in one eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 20, 48, and 72 hours after treatment, and at 4 and 7 days if irritation persisted. The test article was used as received.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0.3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Group Draize scores
24 h 48 h 72 h 4 d 7 d
Unwashed 0.3 0 0 - -
Interpretation of results:
GHS criteria not met
Conclusions:
The test material is not an ocular irritant to rabits under the conditions of the test.
Executive summary:

In this guideline equivalent study (EPA OPP 81 -4), conducted prior to the adoption of the OECD principles of GLP in 1992, the test material (EC 205-363-0) was not considered an ocular irritant to the rabbit. Six New Zealand White rabbits were treated with 0.1ml of the unchanged substance in one eye, the contralateral eye served as a control. Rabbits were observed for corneal opacity, iritis, and conjunctivitis at 24, 48, and 72 hours after treatment, and again 4 day and 7 days after treatment. Results were scored accoring to the Draize criteria. The test material induced a mean overal irritation score of 0.3 at 24 hours, this was fully reversible at the 48 hour observation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The registered substance failed to induce sufficient skin or eye irritation to meet the criteria for classification as a skin or eye irritant in accordance with the Classification, Labelling, and Packaging (CLP) regulation (1272/2008).