9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester

Endpoint summary

Description of key information

Skin irritation/corrosion: not irritating (OECD 404, GLP)

Eye irritation/corrosion: not irritating (OECD 405, GLP);

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:

2002-12-17 to 2002-12-20

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:

2002-04-24

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the freezer protected from light, under nitrogen

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 8 - 10 weeks old
- Weight at study initiation: 1823 - 1904 g
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56 x 44 x 37.5 cm)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g/day; pressed hay (BMI, Helmond, the Netherlands) twice a week
- Water (ad libitum): tap-water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative Humidity: 30 - 70 %
- Air changes: approx. 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: corn oil

Controls:

no

Amount / concentration applied:

NOTE: since the test substance did not mix with water, the powdery test substance was moistened with corn oil, heated up to approximately 40 °C, immediately before application, to ensure close contact with the animal's skin.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams of the lest substance moistened with corn oil

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

NOTE: all available data relevant to the potential dermal irritation/corrosivity of the substance indicated that no significant irritation was to be expected. Therefore, this in-vive skin irritation study was started with three animals.

TEST SITE
- Area of exposure, % coverage and type of wrap: approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10 x 15 cm²). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.
The test substance was moistened with the vehicle and applied to the skin of one flank, using a metalline patch' of 2 x 3 cm. The patch was mounted on Micropore tape', which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin cleaned of residual test substance using water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance

SCORING SYSTEM: Draize scale

OBSERVATIONS:
- Mortality/Viability: twice daily
- Toxicity: at least once daily
- Body Weight: day of treatment (prior to application) and at termination

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: see "Remarks"

Remarks:

dry remnants of the test substance present 1 hour after application

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: see "Remarks"

Remarks:

dry remnants of the test substance present 1, 24 and 48 hours after application

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Remarks on result:

other: see "Remarks"

Remarks:

dry remnants of the test substance present 1 hour and 24 hours after application

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Four hours exposure to 0.5 g of TESAC resulted in well-defined erytherna and slight oederna in lhe treated skin-areas of two rabbits and well-defined erythema and very slight oedema in the other animal. The skin irritalion had resolved within 48 hours.

There was no evidence of a corrosive effect on the skin.

No staining of the treated skin by the test substance was observed. Sticky remnants of the test substance were observed in all animals immediately after removal of the bandage. Dry remnants of the test substance were present on the skin 1 hour after treatment in one animal, 24 hours after treatment in the second animal and 48 hours after treatment in the last animal.

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the skin.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as 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:

2003-01-07 to 2003-01-10

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:

1987-02-24

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the freezer protected from light, under nitrogen

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test substance was ground to a powder using a mortar and pestle prior to weighing.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 11 - 13 weeks old
- Weight at study initiation: 2573 - 2680 g
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56 x 44 x 37.5 cm)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g/day; pressed hay (BMI, Helmond, the Netherlands) twice a week
- Water (ad libitum): tap-water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative Humidity: 30 - 70 %
- Air changes: approx. 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 41.6 mg (41.2 - 42.0 mg) of the test substance (a volume of approx. 0.1 mL) in the conjunctival sac of one of the eyes after gently pulling the
lower lid away from the eyeball.

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

approx. 1, 24, 48 and 72 hours after instillation of the test substance

Duration of post- treatment incubation (in vitro):

not applicable

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE:
lmmediately after the 24-hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial
damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

OBSERVATIONS:
- Mortality/Viability: twice daily
- Toxicity: at least once daily
- Body Weight: day of treatment (prior to application) and at termination

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: see "Remarks"

Remarks:

Discharge and remnants of the test item were observed at the 1 hour observation.

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal # 2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: see "Remarks"

Remarks:

Discharge was observed at the 1 and 24 hour observations. Remnants of the test substance in the eye at the 1 hour observation.

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal 2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: see 2Remarks"

Remarks:

Discharge and remnants of the test item were observed at the 1 hour observation.

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Instillation of approximately 42 mg of the test substance (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in irritation of the conjunctivae, which was seen as
redness, chemosis and discharge. The irritation had completely resolved within 48 hours in one animal and in 72 hours in the other animals.
No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.
No staining of (peri) ocular tissues by the test substance was observed.
Remnants of the test substance were present in the eyes of all animals on day 1.

Other effects:

- Lesions and clinical observations: no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the eyes.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as 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 substance was not observed to be irritating to the skin in a reliable in vivo skin irritation study according to OECD 404.

Eye irritation

The substance was not observed to be irritating to the eyes in a reliable in vivo eye irritation study according to OECD 405.

Justification for classification or non-classification

Skin irritation

The substance does not possess skin irritating potential based on an in vivo skin irritation studies according to OECD 404 (2002). The substance does not require classification as skin irritating according to Regulation (EC) No 1272/2008 and its subsequent adaptations.

Eye irritation

The substance does not possess an eye irritating potential based on in vivo eye irritation studies according to OECD 405 (1987). The substance does not require classification as eye irritating according to Regulation (EC) No 1272/2008 and its subsequent adaptations.