Registration Dossier

Administrative data

Description of key information

No skin irritation observed. Mildly irritating to eyes according to CLP (EC1272/2008).

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: JMAFF Guidelines (2000) including the most recent partial revisions.
Qualifier:
according to
Guideline:
other: - United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.2500, Acute Dermal Irritation. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-98-196, August 1998, Acute Dermal Irritation.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Other effects:
Brown/orange staining of the treated skin by the test substance was observed throughout the observation period, which did not hamper the scoring of the skin reactions.

No remnants of the test substance were present on the skin
Summary from report of the skin irritation
Primary skin irritation/ corrosion study with Everzol Orange ED-G Crude in the rabbit ( 4hr semi-occlusive application). Three rabbits were exposed to 0.5 grams of Everzol Orange ED-G Crude, moistened with 0.5 ml water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. No skin irritation was caused by 4 hours exposure to Everzol Orange ED-G Crude. Brown/orange staining of the treated skin by the test substance was observed throughout the observation period, which did not hamper the scoring of the skin reactions. No remnants of the test substance were present on the skin. Based on these results, Everzol Orange ED-G Crude does not have to be classified and has no obligatory labeling requirement for skin irritation according to GHS and EC 67/548/EEC.
Interpretation of results:
GHS criteria not met
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
GLP compliance:
yes
Species:
other: Albino rabbit, New Zealand White
Amount / concentration applied:
.1 ML
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks:
7 days after dosing
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks:
7 days after dosing
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks:
7 days after dosing
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Remarks:
7 days after dosing
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks:
7 days after dosing
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks:
7 days after dosing
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
Yellow/orange staining of (peri) ocular tissues by the test substance was observed throughout the study period.

Yellow/orange staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

Summary from report of the eye irritation

Single samples of approximately 73.2 mg of Everzol Orange ED-G Crude (a volume of approximately 0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation.

Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in all animals.

No radial irritation or corneal opacity was observed and treatment of the eye with 2 % fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Summary from report of the skin irritation

Primary skin irritation/ corrosion study with Everzol Orange ED-G Crude in the rabbit ( 4hr semi-occlusive application). Three rabbits were exposed to 0.5 grams of Everzol Orange ED-G Crude, moistened with 0.5 ml water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.

No skin irritation was caused by 4 hours exposure to Everzol Orange ED-G Crude.

Brown/orange staining of the treated skin by the test substance was observed throughout the observation period, which did not hamper the scoring of the skin reactions. No remnants of the test substance were present on the skin.

Summary from report of the eye irritation

Single samples of approximately 73.2 mg of Everzol Orange ED-G Crude (a volume of approximately 0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation.

Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in all animals.

No radial irritation or corneal opacity was observed and treatment of the eye with 2 % fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage.

Justification for classification or non-classification

Everzol Orange ED-G Crude does not have to be classified and has no obligatory labeling requirement for skin irritation according to CLP (EC1272/2008) and DSD (67/548/EEC).

Based on these results, conjunctival redness >= 2 and full reverse in 7 days, Everzol Orange ED-G Crude has the following obligatory requirement for eye irritation:

- mildly irritating to eyes category 2 according to CLP (EC1272/2008).

- does not have to be classified and has no obligatory labeling according to DSD (67/548/EEC).