NITTA

Endpoint summary

Description of key information

Skin irritation

The substance is not a skin irritant, rabbit, OECD 404, Jones & Collier (1987)

Eye irritation

The substance is not an eye irritant, rabbit, OECD 405, Jones & Collier (1987)

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:

29 April 1987 to 6 May 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, UK and David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: ca. 12 - 16 weeks
- Weight at study initiation: 2.40 - 3.12 kg
- Housing: Animals were housed individually in suspended metal cages
- Diet: ad libitum (Rabbit Diet, Preston Farmers Ltd., New Leake, Lincolnshire)
- Water: ad libitum
- Acclimation period: 5 days (minimum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ca. 24 hours before treatment, the dorsal/flank fur was clipped free of fur
- Coverage: each animals was treated by dermal application of 0.5 mL of test material
- Type of wrap if used: the test material was covered with a gauze patch of 2.5 x 2.5 cm. The patch was secured with surgical tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): four hours after application, the dressing was removed and the skin cleaned by gentle swabbing with cotton wool soaked in diethyl ether.

SCORING SYSTEM: skin reaction were scored using the Draize scoring system 1, 24, 48 and 72 hours after removal of test material.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Very slight erythema was noted at one treated skin site one hour after removal of the patches. Very slight erythema with or without oedema was noted at all treated skin sites at the 24-hour observation and at two treated skin sites at the 48 and 72-hour observations. Desquamation was also noted at one of these treated skin sites at the 72-hour observation. Desquamation only was apparent at two treated skin sites seven days after treatment.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study the test material was found not to be a skin irritant.

Executive summary:

The potential of the test material to cause skin irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 404.

During the study three rabbits were exposed to 0.5 mL test material onto clipped skin for 4 hours using a semi-occulsive dressing. Skin reactions were assessed 1, 24, 48 amd 72 hours after exposure.

Exposure to the test material resulted in very slight erythema at one treated skin site one hour after removal of the patches. Very slight erythema with or without oedema was noted at all treated skin sites at the 24-hour observation and at two treated skin sites at the 48 and 72-hour observations. Desquamation was also noted at one of these treated skin sites at the 72-hour observation. Desquamation only was apparent at two treated skin sites seven days after treatment.

Based on these results, the test material was concluded not to be a skin irritant.

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

Study period:

1 June 1987 to 5 June 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, UK and David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: ca. 12 - 16 weeks
- Weight at study initiation: 2.36 - 3.32 kg
- Housing: Individually housed in suspended metal cages
- Diet: ad libitum (Rabbit Diet, Preston Farmers Ltd., New Leake, Lincolnshire)
- Water: ad libitum
- Acclimation period: 5 days (minimum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21 °C
- Humidity (%): 65 - 68 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL test material was instilled into the in the conjunctival sac of the right eye of each rabbit by gently pulling the lower lid away from the eyeball. The lids were then gently held together for ca. 1 second to prevent loss of the test material. The other eye remained untreated and served as the control.

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

The eys of each animal were examined 1, 24, 48 amd 72 hours after instillation of the test material.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: The irritation reactions were scored using the Draize System.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light sourced from a standard ophthalmoscope.

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No adverse corneal effects were noted in any treated eye during the observation period.
Iridial inflammation was confined to one treated eye and noted only at the one hour observation, reversible and not observed 24 hours after treatment.
Moderate conjunctival chemosis was noted in all treated eyes one hour after treatment but was reversible and not observed 24 hours after treatment. No conjunctival irritation was noted in any treated eye at subsequent 48 and 72 hour observations.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study the test material was not found to be irritating to the eyes.

Executive summary:

The potential of the test material to cause eye irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 405.

During the study single samples of test material (0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation of the test material resulted in no adverse corneal effects in any treated eye during the observation period. Iridial inflammation was confined to one treated eye and noted only at the one hour observation, reversible and not observed 24 hours after treatment. Moderate conjunctival chemosis was noted in all treated eyes one hour after treatment but was reversible and not observed 24 hours after treatment. No conjunctival irritation was noted in any treated eye at subsequent 48 and 72 hour observations.

Based on the results of this study, the test material is not considered to be an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The potential of the test material to cause skin irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 404.

During the study three rabbits were exposed to 0.5 mL test material onto clipped skin for 4 hours using a semi-occulsive dressing. Skin reactions were assessed 1, 24, 48 amd 72 hours after exposure.

Exposure to the test material resulted in very slight erythema at one treated skin site one hour after removal of the patches. Very slight erythema with or without oedema was noted at all treated skin sites at the 24-hour observation and at two treated skin sites at the 48 and 72-hour observations. Desquamation was also noted at one of these treated skin sites at the 72-hour observation. Desquamation only was apparent at two treated skin sites seven days after treatment.

Based on these results, the test material was concluded not to be a skin irritant.

Eye irritation

The potential of the test material to cause eye irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 405.

During the study single samples of test material (0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation of the test material resulted in no adverse corneal effects in any treated eye during the observation period. Iridial inflammation was confined to one treated eye and noted only at the one hour observation, reversible and not observed 24 hours after treatment. Moderate conjunctival chemosis was noted in all treated eyes one hour after treatment but was reversible and not observed 24 hours after treatment. No conjunctival irritation was noted in any treated eye at subsequent 48 and 72 hour observations.

Based on the results of this study, the test material is not considered to be an eye irritant.

Justification for classification or non-classification

The substance does not fulfil the classification criteria for classification as a skin or eye irritant according to European Regulation (EC) No 1272/2008.