Registration Dossier

Administrative data

Description of key information

Skin Irritation: rabbit; key; kl2; (3% solution): not irritating

Human volunteer patch test (supporting) (1% solution): not irritating

Eye Irritation rabbit; WoE2; kl2; (3% solution): not irritating

                    rabbit; WoE1; kl3 (100% substance): corrosive

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
Study period:
April 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: two sites (both clipped), one unabrated skin and one abrated skin
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 3 % solution
Duration of treatment / exposure:
4h
Observation period:
24h and 72h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: one square inch
- % coverage: not specified
- Type of wrap if used: plastic weap secured with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified, reported that excess materal was removed from the site.
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24h and 72h

SCORING SYSTEM:
- Method of calculation: Draize scoring system
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.25
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Stepanquat ML 3% solution was applied on the skin of rabbits. The primary dermal irritation score was calculated to be 0.25 indicating that the test substance is not a skin irritant.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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:
May 1958
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.1 ml of a test item solution was instillated into the eyes of each of three albino rabbits. The right eye remained unwashed and the left eyes were irrigated with water for 20s after the instillation of the material. With the aid of fluorescein staining and a hand-slit-lamp, the eyes were examined one hour, four hours and 24 hours after treatment, and where possible daily after, until the animals were sacrificed. Microscopic examination of corneas were also carried out.
GLP compliance:
no
Species:
rabbit
Strain:
other: albino
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1ml 100% test substance, 10% test substance, 1.5% test substance
Duration of treatment / exposure:
20s
Observation period (in vivo):
24 hours (min) - 23 days (max)
Irritation parameter:
conjunctivae score
Basis:
other: 100%
Time point:
24 h
Reversibility:
not fully reversible within: 22 days
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
other: 100%
Time point:
24 h
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
other: 10 %
Time point:
24 h
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
other: 1.5%
Time point:
24 h
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Undiluted test substance caused corneal damage when instilled into the eyes of rabbits
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In the skin irritation study the test item 3% (0.5ml) was applied in two sites, one unabrated skin and one abrated skin, approximately 1 square inch each of three albino rabbits. The application site were covered with a two layer gauze patch secured with non-irritating porous adhesive tape and the entire site was covered with 4 mil palstic wrap and secured with more adhesive tape. At the end of the 4 hour contact period excess material was remoed from the sites. Dermal irritation observations were performed at 24 and 72 hours after the test materail was applied to the sites. Grading and scoring was done according to the Draize. Primary irritation score was calculated to be 0.25 indicating that Stepanquat ML 3% is not a skin irritant.

In the human patch test 206 volunteers were exposed to test substance (1%). Cloth containg Avitex R and untreated cloth were used as a controls. Patched of one-inch square were applied to the arms of 97 men and to the arms of 109 women and held in place for six days. Following a ten days period, new patches of the same material were applied and removed after 28 hours. The skin under patched were was examined 24hours and six days after initial application. Irritation which could be attributed to the test materials was not observed at any of the examination, indicating that neither primary irritation nor allergic contact dermatitis had resulted in any of the 206 subjects.

Eye Irritation

In the eye irritation study the test item (Stepanquat ML 3%) was administered into one eye of each of three albino rabbits. The eyes were observed and scored at 24, 48 and 72 hours. Instilliation of the sample into the eyes of rabbits produced no positive eye irritating reactions in any of the three test subjects indicating that Stepanquat ML 3% in not a eye irritant.

In the other study 0.1 ml of a 100%,10% and 1.5% test item was instillated into the eyes of each of three albino rabbits. The right eye remained unwashed and the left eyes were irrigated with water for 20s after the instillation of the material. With the aid of fluorescein staining and a hand-slit-lamp, the eyes were examined one hour, four hours and 24 hours after treatment, and where possible daily after, until the animals were sacrificed. Microscopic examination of corneas were also carried out. Undiluted test substance caused corneal damage when instilled into the eyes of rabbits. At concentration 10% and 1.5% it did not corneal damage but did cause mild conjuctival irritation.

Justification for classification or non-classification

Stepanquat ML is classified for skin irritant Cat 2 according to CLP Regulation 1272/2008. This conclusion is made (as worst case scenrio) as no skin irritation studies are not conducted for the substance and the substance has been shown to be damaging to the eyes.

WoE analysis indicate that Stepanquat ML need to be classified for eye dam Cat 1 according to CLP Regulation 1272/2008.