Phosphoric acid, 2-ethylhexyl ester

Endpoint summary

Description of key information

in vivo skin irritation/corrosion study = Corrosive; DiDonato, L.J. (2011); OECD 404 (Acute Dermal Irritation/Corrosion)
in vivo skin irritation/corrosion study = Corrosive; Kreiling, R. (1998); EU Method B.4. (Acute Toxicity: Dermal Irritation/Corrosion)
in vitro skin irritation/corrosion study = non corrosive; Heppenheimer, A. (2009); OECD 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

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:

Experimental Start Date: 31 May 2011; Experimental Term Date: 16 Jun 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

The dermal score for the initial animal was not performed on Day 14, but was performed on Day 15. This deviation did not appear to have an impact on the outcome of the study since the scores had not resolved and the conclusion did not change.

GLP compliance:

yes

Remarks:

Report includes EPA GLP Compliance letter

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Animals were received from Millbrook Breeding Labs, Amherst, MA- Age at study initiation: The animals were approximately 3 months old.- Weight at study initiation: The pretest body weight range was 2.9 - 3.1 kg- Housing: The animals were individually housed in suspended cages.- Diet (e.g. ad libitum): Fresh Rabbit Chow (Diet #5321) was provided daily.- Water (e.g. ad libitum): Water was available as libitum- Acclimation period: At least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): The animal room was temperature controlled.- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped free of hair

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): The test article was dosed by volume, 0.5 ml/site.

Duration of treatment / exposure:

Exposure periods of 3 minutes (for initial animal), 1 hour (for initial animal) and 4 hours (for all animals).

Observation period:

Up to 15 days.

Number of animals:

3 (1 initial animal then two additional animals).

Details on study design:

TEST SITE- Area of exposure: Each dose site was approximately 6 cm2.- Type of wrap if used: Initially, one rabbit was dosed sequentially on sites #1, 2 and 3. The test article was placed under a 2 x 3 cm gauze patch. Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The rabbit was gently held in place and a piece of porous dressing was secured with non-irritating tape over dose site #1 (semi-occlusive) for the 3 minute exposure period. The torso was covered with a piece of porous dressing large enough to cover dose sites 2 & 3 with at least 5 cm square to spare on all sides of the gauze patch. Porous, non-irritating tape was used to encircle the trunk of the animal.REMOVAL OF TEST SUBSTANCEThe dressing and test article patch covering site #1 were removed at 3 minutes post dose, over site #2 at 1 hour post dose and the torso wrappings and patch covering site #3 at 4 hours post dose. All sites were gently washed with distilled water to remove residual test substance.DOSING OF ADDITIONAL ANIMALSSince no evidence of a corrosive or severely irritating effect was observed in the initial animal, two additional animals were added to the study. The animals were dosed at site #3 with 0.5 ml of test article. After an exposure period of 4 hours, the wrappings and patches were removed and the sites gently washed with distilled water.SCORING SYSTEM:Initial animal: Site #1 was scored for dermal irritation immediately and at 60 minutes following patches removal for the 3 minute exposure. Site #2 was scored at 60 minutes following the 1 hour exposure.All animals: Site #3 was scored at 60 minutes and at 24, 48 and 72 hours and on Days 7 and 15 for the initial animal and at 24, 48 and 72 hours and on Days 7 and 14 for the two additional animals following the 4 hour exposure.Erythema and edema were scored according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Any additional signs were described. Draize scoring scheme:Erythema & Eschar No erythema: 0Very slight erythema (barely perceptible): 1Well defined erythema: 2Moderate to severe erythema: 3Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4Edema No edema: 0Very slight edema (barely perceptible): 1Slight edema (edges of area well-defined by definite raising): 2Moderate edema (raised approximately 1.0 mm): 3Severe edema (raised more than 1.0 mm, extending beyond the area of exposure): 4

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #1

Remarks:

initial animal

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #1

Remarks:

initial animal

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #1

Remarks:

initial animal

Time point:

7 d

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Skin felt thickened and as though it had separated from the underlying tissue. Shiny areas were also observed.

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #1

Remarks:

initial animal

Time point:

other: 15 days

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Shiny areas observed.

Irritation parameter:

edema score

Remarks:

(4 hour exposure)

Basis:

animal #1

Remarks:

initial animal

Time point:

other: 1 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Irritation parameter:

edema score

Remarks:

(4 hour exposure)

Basis:

animal #1

Remarks:

initial animal

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: skin felt thickened on dose site after 48 h & 72 h

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #2

Remarks:

additional animal

Time point:

other: 1 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #2

Remarks:

additional animal

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #2

Remarks:

additional animal

Time point:

7 d

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Skin felt thickened and as though it had separated from the underlying tissue.

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #2

Remarks:

additional animal

Time point:

14 d

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Shiny areas observed.

Irritation parameter:

edema score

Remarks:

(4 hour exposure)

Basis:

animal #2

Remarks:

additional animal

Time point:

other: 1 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

edema score

Remarks:

(4 hour exposure)

Basis:

animal #2

Remarks:

additional animal

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: skin felt thickened on dose site and as though skin had seperated from underlying tissue

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #3

Remarks:

addiitonal animal

Time point:

other: 60 m

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #3

Remarks:

additional animal

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #3

Remarks:

additional animal

Time point:

7 d

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Skin felt thickened

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #3

Remarks:

additional animal

Time point:

14 d

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Shiny areas observed

Irritation parameter:

erythema score

Remarks:

(4 hour exposure)

Basis:

animal #3

Remarks:

additional animal

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

edema score

Remarks:

(4 hour exposure)

Basis:

animal #3

Remarks:

additional animal

Time point:

other: 1 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

edema score

Remarks:

(4 hour exposure)

Basis:

animal #3

Remarks:

additional animal

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: skin felt thickened on dose site

Irritant / corrosive response data:

Dermal Observations (Table 1 - attached background material).Initial animal:No erythema or edema was observed immediately following or at 60 minutes after patch removal following the 3 minute exposure. Slight erythema and no edema was observed at 60 minutes following the 1 hour exposure. Slight erythema and very slight edema was observed at 60 minutes, 24, 48 and 72 hours after patch removal following the 4 hour exposure. At 48 and 72 hours, the skin felt thickened. On Day 7, erythema was severe. The skin felt thickened and as though it had separated from the underlying tissue. Shiny areas were also observed. On Day 15, erythema was severe with shiny areas. No edema was observed on Days 7 or 15.2 additional animals:Erythema was slight to moderate at 1 hour post patch removal following the 4 hour exposure. Erythema was slight at 24 hours and 48 hours and very slight to slight at 72 hours. At 48 and 72 hours, the skin felt thickened and as though it had separated from the underlying tissue. Edema was slight at 1 hour and very slight at 24, 48 and 72 hours after patch removal following the 4 hour exposure. On Day 7, erythema was severe. The skin felt thickened for both animals and as though it had separated from the underlying tissue for one animal. On Day 14, erythema was severe with shiny areas. No edema was observed on Days 7 or 14.

Other effects:

Systemic Observations and Body Weights (Table 1 - attached background material).There were no abnormal physical signs noted during the observation period.

See attached background material for Table 1: Dermal Observations, Body Weights and Systemic Observations.

Interpretation of results:

corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The substance is considered to be corrosive.

Executive summary:

Objective:

To determine the irritant or corrosive effects, if any, of a test article when applied to the skin of a rabbit. This study was designed to comply with standards set forth in OECD Guideline for Testing of Chemicals, Number 404 Acute Dermal Irritation/Corrosion, adopted April 24, 2002.

Method Synopsis:

Since the test article was suspected to be a dermal irritant/corrosive substance, one healthy male New Zealand White rabbit was dosed dermally with the test article. The test article (0.5 ml) was applied dermally to three intact sites for an exposure period of 3 minutes on site #1, 1 hour on site #2 and 4 hours on site #3. Erythema and edema were scored immediately after patch removal following the 3 minute exposure and at 60 minutes after each patch removal for the 1 and 4 hour exposure. Site #3 was scored again at 24, 48 and 72 hours. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Since the reaction of the initial animal did not produce a corrosive or severely irritating effect, two additional animals (males) were added to the study. The two animals were dosed at site #3 for a four hour exposure. Erythema and edema were scored at 60 minutes, and at 24, 48 and 72 hours and on Days 7 and 15 for the initial animal and at 24, 48 and 72 hours and on Days 7 and 14 for the two additional animals.

Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Body weights of all animals were recorded pre-test, 72 hours and at termination

Summary:

Initial animal:

No erythema or edema was observed immediately following or at 60 minutes after patch removal following the 3 minute exposure. Slight erythema and no edema was observed at 60 minutes following the 1 hour exposure. Slight erythema and very slight edema was observed at 60 minutes, 24, 48 and 72 hours after patch removal following the 4 hour exposure. At 48 and 72 hours, the skin felt thickened. On Day 7, erythema was severe. The skin felt thickened and as though it had separated from the underlying tissue. Shiny areas were also observed. On Day 15, erythema was severe with shiny areas. No edema was observed on Days 7 or 15.

2 additional animals:

Erythema was slight to moderate at 1 hour post patch removal following the 4 hour exposure. Erythema was slight at 24 hours and 48 hours and very slight to slight at 72 hours. At 48 and 72 hours, the skin felt thickened and as though it had separated from the underlying tissue. Edema was slight at 1 hour and very slight at 24, 48 and 72 hours after patch removal following the 4 hour exposure. On Day 7, erythema was severe. The skin felt thickened for both animals and as though it had separated from the underlying tissue for one animal. On Day 14, erythema was severe with shiny areas. No edema was observed on Days 7 or 14.

Conclusion:

The substance is considered to be corrosive.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 June 1998 to 14 July 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with international guidelines and in accordance with the principles of GLP.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or test system and environmental conditions:

Origin: Charles River Deutschland GmbH, 88353 KibleggBodyweight at Start of Study: 2.0 - 2.8 kgAnimal Maintenance: In fully air-conditioned rooms in separate cages arranged in a batteryRoom temperature: 20 ± 3°C Relative Humidity: 50 ± 20 % Lighting Time: 12 hours dailyAcclimatisation: 1 week under study conditionsFood: Ssniff K-H (V2333), ad libitum, and hay (approx. 15 g daily)Water: water from automatic water dispenser, ad libitumAnimal Identification: Numbered ear tags

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL applied to shaved area on dorsal region of the body.

Duration of treatment / exposure:

3 minutes (3 animals); 4 hours (1 animal)

Observation period:

1, 24, 48 and 72 h, and 7 and 14 days after removal of the patches

Number of animals:

Number of Animals: 1 (treatment 4 hours), 3 (treatment 3 minutes)

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

3

Reversibility:

not reversible

Remarks on result:

other: 4h treatment

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

4

Reversibility:

not reversible

Remarks on result:

other: 4h treatment

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

14 d

Score:

4

Reversibility:

not reversible

Remarks on result:

other: 4h treatment

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

2

Reversibility:

not reversible

Remarks on result:

other: 4h treatment

Irritation parameter:

edema score

Basis:

animal #1

Time point:

14 d

Score:

2

Reversibility:

not reversible

Remarks on result:

other: 4h treatment

Irritant / corrosive response data:

4 Hour Treatment:30 -60 minutes after removal of the plaster the animal showed a very slight erythema and a slight oedema. Moderate up to severe erythema and slight oedema were observed one up to 14 days after removal of the plaster. During the observation period the treated skin was dry, rough, indurated, scabbed, encrusted and discolored beige. 14 days after the removal of the plaster, a scar was noted.3 Minute Treatment30 - 60 minutes to seven days after the removal of the plaster the animals showed very slight up to moderate erythema and sporadically very slight up to slight oedema. 14 days after removal of the plaster erythema and oedema formation were reversible. During the observation period the treated skin areas were sporadically dry, rough, fine scaly and discoloured beigie.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the test item is corrosive to the skin.

Executive summary:

Testing for primary dermal irritation in the rabbit showed that the substance is corrosive to the skin.

Reference 3

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a recognised testing guideline and in accordance with GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test system:

artificial membrane barrier model

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

See "Details on study design"

Duration of treatment / exposure:

240 minutes

Details on study design:

An in vitro test was used to ascertain the potential of Servoxyl VPTZ 100 to cause skin irritation. The system is composed of two components, a synthetic macromolecular biobarrier and a chemical detection system (CDS). Test items were applied to the upper surface of the macromolecular biobarrier. Corrosive substances are able to disrupt the integrity of the biobarrier, leading to penetration of the test item through the biobarrier into the CDS located beneath. The presence of the test item in the CDS results in a colour change that is detected visually. The time it takes a test item to penetrate the biobarrier into the CDS is inversely proportional to its corrosivity: the more corrosive test item is, the shorter time required affects a colour change. Non-corrosive test items do not disrupt the biobarrier, or disrupt the biobarrier too slowly to be identified as corrosive.Three different tests were performed, these being a Qualify test, a Categorisation test and a Classification test. The Qualify test was conducted in order to test whether the test system is suitable for this test design. 150 uL of the test item were applied into the "Qualify Test Vial". The vial was shaken until the solution appeared homogenous, and incubated for at least 1 minute. Afterwards, the colour change was noted.The Categorisation test was performed in order to assign a "Category" to the test item. 150 uL of the test item were applied to the "Category A Vial" as well as to the "Category B Vial". The vials were shaken until the solution appeared homogenous. After at least 1 minute the colour change was monitored.For the Classification test approximately 500 uL of the test item was applied on each of quadruplicate biobarriers. The biobarriers were placed atop vials containing the CDS reagent. The time needed to corrode the biobarrier and induce a distinct change in the colour of the CDS reagent was monitored for each of the vials.

Irritation / corrosion parameter:

other: colour change in CDS

Run / experiment:

1 minute & 240 minutes

Remarks on result:

no indication of irritation

Remarks:

No colour change was detected

The test item induced a change in colour in the qualify test after 1 minute incubation. Since a change in colour was visible in the "Qualify Test Vial", the test item was considered to be suitable for the next step.The test item induced a change in colour in the Category A vial but not in the Category B vial after 1 minute incubation. Therefore, the test item was classified according to category 1. In the classification test the test item did not induce a colour change to the CDS within 240 minutes. Servoxyl VPTZ 100 can therefore be considered to be non corrosive.

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Servoxyl VPTZ 100 is non corrosive to skin.

Executive summary:

An in vitro study was performed to assess the corrosive potential of the test item Servoxyl VPTZ 100 by means of the In Vitro Membrane Barrier Test for Skin Corrosion using the Corrositex® test kit. The test substance was found to be non-corrosive.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation/Corrosion

Objective:

To determine the irritant or corrosive effects, if any, of a test article when applied to the skin of a rabbit. This study was designed to comply with standards set forth in OECD Guideline for Testing of Chemicals, Number 404 Acute Dermal Irritation/Corrosion, adopted April 24, 2002.

Method Synopsis:

Since the test article was suspected to be a dermal irritant/corrosive substance, one healthy male New Zealand White rabbit was dosed dermally with the test article. The test article (0.5 ml) was applied dermally to three intact sites for an exposure period of 3 minutes on site #1, 1 hour on site #2 and 4 hours on site #3. Erythema and edema were scored immediately after patch removal following the 3 minute exposure and at 60 minutes after each patch removal for the 1 and 4 hour exposure. Site #3 was scored again at 24, 48 and 72 hours. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Since the reaction of the initial animal did not produce a corrosive or severely irritating effect, two additional animals (males) were added to the study. The two animals were dosed at site #3 for a four hour exposure. Erythema and edema were scored at 60 minutes, and at 24, 48 and 72 hours and on Days 7 and 15 for the initial animal and at 24, 48 and 72 hours and on Days 7 and 14 for the two additional animals.

Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Body weights of all animals were recorded pre-test, 72 hours and at termination

Summary:

Initial animal:

No erythema or edema was observed immediately following or at 60 minutes after patch removal following the 3 minute exposure. Slight erythema and no edema was observed at 60 minutes following the 1 hour exposure. Slight erythema and very slight edema was observed at 60 minutes, 24, 48 and 72 hours after patch removal following the 4 hour exposure. At 48 and 72 hours, the skin felt thickened. On Day 7, erythema was severe. The skin felt thickened and as though it had separated from the underlying tissue. Shiny areas were also observed. On Day 15, erythema was severe with shiny areas. No edema was observed on Days 7 or 15.

2 additional animals:

Erythema was slight to moderate at 1 hour post patch removal following the 4 hour exposure. Erythema was slight at 24 hours and 48 hours and very slight to slight at 72 hours. At 48 and 72 hours, the skin felt thickened and as though it had separated from the underlying tissue. Edema was slight at 1 hour and very slight at 24, 48 and 72 hours after patch removal following the 4 hour exposure. On Day 7, erythema was severe. The skin felt thickened for both animals and as though it had separated from the underlying tissue for one animal. On Day 14, erythema was severe with shiny areas. No edema was observed on Days 7 or 14.

Conclusion:

The substance is considered to be corrosive.

Eye Irritation:

An in vivo skin irritation/corrosion study showed the substance to be corrosive.

In accordance with column 2 of REACH Annex VII (8.2) and Annex VIII (8.2.1), neither an in vitro or in vivo eye irritation study has been conducted as the substance is classified as corrosive to the skin.

The substance can therefore be considered to lead to serious eye damage.

Respiratory Irritation:

As the substance is a corrosive, it can be assumed that it may have the potential to cause respiratory irritation if inhaled.

Justification for selection of skin irritation / corrosion endpoint:
The most recent in vivo studies indicating corrosivity of the skin is considered more reliable than the available in vitro study that indicates that the substance is not corrosive. The most recent study has been chosen as the endpoint for selection. All submitted studies were conducted in accordance with internationally accepted guidelines and the principles of GLP.

Justification for selection of eye irritation endpoint:
The substance is classified as corrosive to the skin and is therefore assumed to be corrosive to the eye. In accordance with column 2 of REACH Annex VII (8.2) and Annex VIII (8.2.1), neither an in vitro or in vivo eye irritation study has been conducted as the substance is classified as corrosive to the skin.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

The results from the skin irritation/corrosion study were evaluated according to the Classification, Labelling and Packaging Regulation (CLP).

The substance is considered to be corrosive based on the effects observed in the skin/irritation study, which produced irreversible damage to the skin following exposure to the test substance for up to 4 hours. Severe effects were still present after 14 days.

The substance is classified as Skin corrosion Category 1; subcategory 1B (exposure of ≥3 minutes to ≤1 hour to cause corrosive effects). This represents a worst case classification for corrosion as the effects observed at the 1 hour exposure site were only scored after 60 minutes and not up to 14 days. Therefore, although the corrosive effects observed in the study were observed for the 4 hour exposure sites, the substance is classified as corrosive subcategory 1B.

Based on the substances corrosive classification, it is considered to cause serious damage to the eye. Therefore, a classification of Eye Damage Category 1 (Irreversible effects on the eye) is assumed and applied.

The substance shall be labelled as corrosive and the hazard statement H314: Causes severe skin burns and eye damage, will apply.