Diiron titanium pentaoxide

Endpoint summary

Description of key information

Acute skin irritation was studied in rabbits using intact skin under occlusive conditions according to OECD 404 (reference 7.3.1 -1). Given the results, no evidence for irritation/corrosion was observed. Studies on eye irritation were performed in rabbits according to OECD 405 (reference 7.3.2 -1). No adverse effects were observed thus indicating that undiluted substance is not irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-02-19 until 1990-03-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Sex: 1 male and 2 females
- Age at study initiation: 16 - 17 weeks
- Mean weight at study initiation: 2.84 kg
- Housing: single in cages type KK 017
- Diet: ad libitum, Altromin Standard Diet TPF 2113
- Water: ad libitum, acidified, fully demineralized water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 42 - 55 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

3 hours after removal of the patches, and then daily for a period of 8 days.

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 24 hours before treatment the backs and flanks of the animals were cautiously shaved with an electric clipper, so that the skin stayed intact.
- Type of wrap: The application sites were wrapped with polyethylene foil which was kept on place by a leather sleeve.

REMOVAL OF TEST SUBSTANCE
- Washing: After 4 hours of occlusive exposure the patches were removed and any test material left was wiped off.

OBSERVATION TIME POINTS
The rabbits were investigated for skin alterations, behaviour, and general conditions 3 hours after removal of the patches, and then daily for a period of 8 days.

SCORING SYSTEM:
- Method of calculation: Skin changes at the application site were evaluated according to Draize.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No indication for skin irritation was observed at any time point.

Other effects:

- Other adverse local effects: Only brown discoloration of the skin was observed on day 1 and 2 of the study due to the coloration of the test item.
- Other adverse systemic effects: All animals survived the observation period. No signs of systemic toxicity were detected. The body weight development of the treated rabbits was inconspicuous.

Interpretation of results:

GHS criteria not met

Conclusions:

No skin irritating potential could be detected.

Executive summary:

The acute skin irritation potential was investigated in three White New Zealand rabbits (1 male and 2 females) following application on the intact skin according OECD TG 404. Aliquots of neat test material (0.5 g) were moistened with water and applied to the intact skin of each rabbit for a 4-hour period under occlusive conditions. The rabbits were examined for skin reactions three hours after removal of the patches and then daily up to eight days. Skin reactions were evaluated and graded according to Draize. No signs of skin irritation were observed at any time point. Based on this study the test item is considered not to be irritating to the skin.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-02-19 until 1990-03-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Sex: 2 male and 1 females
- Age at study initiation: 16 - 17 weeks
- Mean weight at study initiation: 2.88 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 42 - 55 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye remained as control

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

Rinsing of the eyes were not performed

Observation period (in vivo):

1 hour after treatment and then daily up to 8 days

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: The rabbits were investigated for eye irritation and for changes in behavior and general condition 1hour after treatment and then daily for a period of 8 days.

SCORING SYSTEM: Local changes of the eye were evaluated according to Draize.

TOOL USED TO ASSESS SCORE: fluorescein
24 hours before treatment ophthalmological examinations were performed after instillation of 0.15% fluorescein solution.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

- Lesions and clinical observations: All animals survived the observation period. No signs of systemic toxicity were seen. The body weight development of the treated rabbits was inconspicuous.
- Other observations: Only brown discoloration of the hairs around the eyes was observed on day 1 and 2 of the study due to the coloration of the test item.

Interpretation of results:

GHS criteria not met

Conclusions:

No eye irritating potential could be detected.

Executive summary:

The test material was tested according OECD TG 405 for acute eye irritation in three New Zealand White rabbits (2 males and 1 female). Aliquots of 0.1 g were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. The rabbits were examined for eye irritation daily up to day 8 of the study. Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in all animals. Based on the results of this study, undiluted test substance is evaluated as non-irritating to the eyes.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

The acute skin irritation potential was investigated in three White New Zealand rabbits (1 male and 2 females) following application on the intact skin according OECD TG 404. Aliquots of neat test material (0.5 g) were moistened with water and applied to the intact skin of each rabbit for a 4-hour period under occlusive conditions. The rabbits were examined for skin reactions three hours after removal of the patches and then daily up to eight days. Skin reactions were evaluated and graded according to Draize. No signs of skin irritation were observed at any time point. Based on this study the test item is considered not to be irritating to the skin.

Eyes

The test material was tested according OECD TG 405 for acute eye irritation in three New Zealand White rabbits (2 males and 1 female). Aliquots of 0.1 g were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. The rabbits were examined for eye irritation daily up to day 8 of the study. Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in all animals. Based on the results of this study, undiluted test substance is evaluated as non-irritating to the eyes.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for skin and eye irritation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.