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Description of key information

Not skin irritant.

Eye irritant

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: animals were housed in single cages.
- Diet: laboratory diet was provided ad libitum. The batch of the diet used for the study was analysed for chemical and microbiological contaminants.
- Water: water was provided ad libitum.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
- Health check: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: approximately 15 changes/hour.
- Photoperiod: 12 hrs dark / 12 hrs light
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: diluted in DMSO (50 %)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
1.0 ml of the solution
Duration of treatment / exposure:
4 hour
Observation period:
72 hours
Number of animals:
Three rabbits
Details on study design:
TEST SITE
- Area of exposure: substance was introduce under a square patch of surgical gauze, measuring 6.5 cm^2.
- Type of wrap if used: animals were immobilized with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve.

OBSERVATION TIME POINTS
30 minutes, 24, 48 and 72 hours.

SCORING SYSTEM:
The irritation was measured by patch test technique on the intact skin.
The resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The irritation score resulted to be 0.

Animal N. Reaction 30 min 24 hrs 48 hrs 72 hrs
Male 201 Erythema 0 0 0 0
Oedema 0 0 0 0
Male 202 Erythema 0 0 0 0
Oedema 0 0 0 0
Male 203 Erythema 0 0 0 0
Oedema 0 0 0 0
Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Non irritating
Executive summary:

The skin irritation potential of the test item was tested using three rabbits (New Zealand white Rabbits). 1.0 ml of the solution (test item diluted in DMSO at 50 %) was placed into skin contact, under occlusive bandage, over a period of 4 hours. The skin reactions were inspected after 30 min., 24, 48 and 72 hours after exposure.

The irritation was measured by patch test technique on the intact skin and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.

The irritation score resulted to be 0.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were in lower than 2.3 for both erythem and oedema in all the treated rabbits; no signs of irritation were recorded during the observation priod. Therefore, the substance does not meet the criteria to be classified as skin irritating, according to the CLP Regulation (EC 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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: animals were housed in single cages.
- Diet: laboratory diet was provided ad libitum. The batch of the diet used for the study was analysed for chemical and microbiological contaminants.
- Water: water was provided ad libitum.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
- Health check: prior to the test, the eye of each rabbit were examined for pre-existing casual injury.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: approximately 15 changes/hour.
- Photoperiod: 12 hrs dark / 12 hrs light
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg of the test material was placed into the conjunctival sac of the animals.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not rinsed.

SCORING SYSTEM:
The eyes were inspected after 30 min., 24, 48 and 72 hours.
Reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).
Irritation parameter:
cornea opacity score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
> 1 - < 3
Irritation parameter:
iris score
Basis:
animal: 2/3
Time point:
24/48/72 h
Score:
>= 1 - < 1.5
Irritation parameter:
conjunctivae score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
> 2
Irritation parameter:
chemosis score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
> 2
Irritant / corrosive response data:
The irritation score resulted to be 51.4.

Animal no Reaction 30 min 24 hrs 48 hrs 72 hrs Mean 24/48/72 hrs
304 Cornea opacity 0 2 3 3 2.67
Iris 0 1 1 2 1.33
Conjuntival chemosis 0 3 3 2 2.67
Conjuntival redness 1 3 3 3 3.00
305 Cornea opacity 0 1 3 3 2.33
Iris 0 0 1 2 1.00
Conjuntival chemosis 0 3 3 2 2.67
Conjuntival redness 1 3 3 3 3.00
306 Cornea opacity 0 2 3 2 2.33
Iris 0 0 1 1 0.67
Conjuntival chemosis 0 3 3 2 2.67
Conjuntival redness 1 3 2 2 2.33

Animal no Reaction 30 min 24 hrs 48 hrs 72 hrs
304 Cornea (A) density 0 2 3 3
(B) area 0 4 4 4
AxBx5 0 40 60 60
Iris (C) 0 1 1 2
Cx5 0 5 5 10
Conjunctiva (D) secretion 1 1 1 1
(E) swelling 0 3 3 2
(F) redness 1 3 3 3
(D+E+F)x2 4 14 14 12
305 Cornea (A) density 0 1 3 3
(B) area 0 4 4 4
AxBx5 0 20 60 60
Iris (C) 0 0 1 2
Cx5 0 0 5 10
Conjunctiva (D) secretion 1 1 1 2
(E) swelling 0 3 3 2
(F) redness 1 3 3 3
(D+E+F)x2 4 14 14 14
306 Cornea (A) density 0 2 3 2
(B) area 0 4 4 4
AxBx5 0 40 60 40
Iris (C) 0 0 1 1
Cx5 0 0 5 5
Conjunctiva (D) secretion 1 1 1 2
(E) swelling 0 3 3 2
(F) redness 1 3 2 2
(D+E+F)x2 4 14 12 12
Interpretation of results:
other: Eye. Irrit. 2 (H319), according to the CLP Regulation (EC 1272/2008)
Conclusions:
Eye irritating
Executive summary:

The eye irritation potential of the test item was tested using three rabbits (New Zealand white Rabbits). 100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals. The left eye served as control.

The eyes were inspected after 30 min., 24, 48 and 72 hours. Treated eyes were not rinsed after application of the test item.

Reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).

The irritation score resulted to be 51.4.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were in the range of 1 - 3 for corneal opacity, 1 - < 1.5 for iritis, higher than 2 for both conjunctival redness and chemosis, in at least two out of three rabbits. No information about the reversibility was available.

Based on the effects observed, the substance is considered as irritating to eye and a classification in category 2 (Eye. Irrit. 2, H319) of the CLP Regulation (EC 1272/2008) is considered as appropriate.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION

The skin irritation potential of Basic Brown 022 was tested in 2 studies comparable to OECD guideline 404.

In the key study, the skin irritation potential of the test item was tested using three rabbits (New Zealand white Rabbits). 1.0 ml of the solution (test item diluted in DMSO at 50 %) was placed into skin contact, under occlusive bandage, over a period of 4 hours. The skin reactions were inspected after 30 min., 24, 48 and 72 hours after exposure. The irritation was measured by patch test technique on the intact skin and the resulting reactions were scored. The irritation score resulted to be 0.

The supporting study was run in the same way, using a liquid sample with low concentration of test item (ca. 17 %) applied as such on the skin. No signs of irritation were reported.

EYE IRRITATION

The eye irritation potential of Basic Brown 022 was tested in 2 studies comparable to OECD guideline 405.

In the key study, a powdered test sample with high purity (ca. 94 %) was used. 100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals. The left eye served as control. The eyes were inspected after 30 min., 24, 48 and 72 hours. The eye was not rinsed. Based on scores of ocular lesions, the substance was considered as eye irritant. No data on reversibility of effects was available, as observations were stopped at 72 h for humane reasons. However, observed effects are likely an overestimate of the actual effects, both for severity and persistence, mainly due to the lack of rinsing.

This was consistent with findings in the supporting study, where a liquid test sample with low purity (ca. 17 % formulated in water) was used. 0.1 ml of the test material was placed into the conjunctival sac of the right eye of the animals. The left eye served as control. The eyes were inspected after 30 min., 24, 48 and 72 hours. The eye was not rinsed. However, due to the low concentration of active substance and the physical form, i.e. liquid instead o solid, effects were less marked compared to the key study.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

The mean values from gradings at 24, 48 and 72 hours were in lower than the threshold value of 2.3 for both erythem and oedema in all the treated rabbits; no signs of irritation were recorded during the observation period. Therefore, the substance does not meet the criteria to be classified as skin irritating, according to the CLP Regulation (EC 1272/2008).

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

The mean values from gradings at 24, 48 and 72 hours were in the range of 1 - 3 for corneal opacity, 1 - < 1.5 for iritis, higher than 2 for both conjunctival redness and chemosis, in at least two out of three rabbits. No information about the reversibility is available, however, reversibility of effects is expected within 21 days.

Based on the effects observed, the substance is considered as irritating to eye and a classification in category 2 (Eye. Irrit. 2, H319) is considered as appropriated.

In conclusion, the substance is not classified for skin irritation; however, it is classified for eye irritation, category 2 (Eye Irrit. 2, H319), according to the CLP Regulation (EC 1272/2008).

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