JAUNE REACTIF 181

Endpoint summary

Description of key information

Skin irritation/corrosion:

In a GLP-compliant skin irritation study, performed according to OECD guideline 404, FAT 40400/A (moistened, 0.5 g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the treated skin was flushed with water and observation were made for an additional 72 hours. The body weight gain of all rabbits was similar. There were no acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

The test substance showed a primary Irritation score (24,48,72 h) of 0.0 and local signs (1 h to 72 h) consisted of grade 0.0 erythema and grade 0.0 edema. No corrosive effect was evident on the skin. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.

 

Eye irritation/corrosion:

In a GLP-compliant eye irritation study, performed according to OECD guideline 405 and EU method B.5, FAT 40400/A (0.1 g) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined for 72 hours. No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred. There were yellow staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all treated animals throughout the 72-hour observation period. The body weight gain of all rabbits was similar. There was no necropsy was performed. All animals were killed and discarded.

The test substance showed a mean chemosis, cornea, iris, and conjunctivae scores of 0.0 during the whole observation period. The primary irritation score (24, 48 and 72 h) was 0.0. No corrosion of the cornea was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive to rabbit eyes.

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:

17 April 1990 to 20 April 1990

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

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identification Code: FAT 40400/A
Batch No.: BG 3247/TV6
Expiration date: 03/95
Stability of test article in vehicle: stable for at least 2 hours
Stability: Stable

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: Males: 15 weeks, Females: 16 weeks
- Weight at study initiation: Males: 2.6 - 2.8 kg, Females: 3.0 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: Pelleted standard Kliba 341, batch 52/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen ad libitum
- Acclimation period: Four days under test conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Remarks:

electric clipper

Vehicle:

water

Remarks:

Test material was applied moistened in distilled water

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

24, 48 and 72 h

Number of animals:

3 (2 males and 1 female)

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was observed 1 day prior to test article administration. On test day 1, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article.

Irritation parameter:

other: Primary Irritation Score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

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:

Irritation: FAT 40400/A showed a primary Irritation score (24, 48, 72 hours) of 0.0 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.0 erythema and grade 0.0 edema.
Corrosion: No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

Coloration: In the area of application yellowish staining of the treated skin by pigment or coloring of the test article was observed in all animals between 1 to 72 hours (termination).
Body weights: The body weight gain of all rabbits was similar.
Toxic symptoms/mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

No necropsy was performed. All animals were killed and discarded.

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40400/A was found to be not irritating or corrosive to rabbit skin.

Executive summary:

In a GLP-compliant skin irritation study, performed according to OECD guideline 404, FAT 40400/A (moistened, 0.5 g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the treated skin was flushed with water and observation were made for an additional 72 h. The body weight gain of all rabbits was similar.There were no acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

The test substance showed a primary Irritation score (24,48,72 h) of 0.00 and local signs (1 h to 72 h) consisted of grade 0.0 erythema and grade 0.0 edema. No corrosive effect was evident on the skin. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.

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:

17 April 1990 to 20 April 1990

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

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identification Code: FAT 40400/A
Batch No.: BG 3247/TV6
Expiration date: 03/95
Stability of test article in vehicle: stable for at least 2 hours
Stability: Stable

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: Males: 15 weeks, Females: 16 weeks
- Weight at study initiation: Males: 2.7 kg, Females: 2.5-2.7 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen).
- Diet: Pelleted standard Kliba 341, batch 52/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen ad libitum
- Acclimation period: Four days under test conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

24, 48 and 72 h

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Details on study design:

The eyes of the animals were observed one day prior to test article administration. The test article (0.1 g) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The irritation was assessed and the corrosive properties of the test article and the staining of the treated eye were described and recorded.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

other: Primary Irritation Score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Irritation: FAT 40400/A showed a primary irritation score of: 0.0 when applied to the conjunctival sac of the rabbit eye.
Corrosion: No corrosion of the cornea was observed at any of the measuring intervals.

Other effects:

Toxic symptoms/mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Coloration: Yellow staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all treated animals throughout the 72-hours observation period.
Body weights: The body weight gain of all rabbits was similar.
No necropsy was performed. All animals were killed and discarded.

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40400/A was found to be not irritating or corrosive to rabbit eyes.

Executive summary:

In a GLP-compliant eye irritation study, performed according to OECD guideline 405 and EU method B.5, FAT 40400/A (0.1 g) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined for 72 h. No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred. There were yellow staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all treated animals throughout the 72-hour observation period. The body weight gain of all rabbits was similar. There was no necropsy was performed. All animals were killed and discarded.

The test substance showed a mean chemosis, cornea, iris, and conjunctivae scores of 0.0 during the whole observation period. The primary irritation score (24, 48 and 72 h) was 0.0. No corrosion of the cornea was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive to rabbit eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the findings in the skin and eye irritation study the test substance does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008