Registration Dossier

Administrative data

Description of key information

Skin Irritation

In accordance with ANNEX VII column 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5)

The experimental pH of the test chemical was 1.77, which is highly acidic in nature. This is suggestive of the test chemical being highly corrosive and damaging to skin. Hence, based on the low pH of the test chemical, the in vivo and in vitro skin irritation studies were considered for waiver.

Eye Irritation

In accordance with ANNEX VII column 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5. the experimental pH of the test chemical was 1.77, which is highly acidic in nature. This is suggestive of the test chemical being highly corrosive and damaging to eyes.

Hence, based on the low pH of the test chemical, the in vivo and in vitro eye irritation studies were considered for waiver.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)
Endpoint:
skin irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)
Endpoint:
eye irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In accordance with ANNEX VII column 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5)

The experimental pH of the test chemical was 1.77, which is highly acidic in nature. This is suggestive of the test chemical being highly corrosive and damaging to skin. Hence, based on the low pH of the test chemical, the in vivo and in vitro skin irritation studies were considered for waiver.

Eye Irritation

In accordance with ANNEX VII column 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5. the experimental pH of the test chemical was 1.77, which is highly acidic in nature. This is suggestive of the test chemical being highly corrosive and damaging to eyes.

Hence, based on the low pH of the test chemical, the in vivo and in vitro eye irritation studies were considered for waiver.

Justification for classification or non-classification

The experimental pH of the test chemical was 1.77, which is highly acidic in nature. This is suggestive of the test chemical being highly corrosive and damaging to skin and eyes.

According to the CLP Regulation (EC n. 1272/2008) and based on the low pH (pH= 1.77) of the test chemical, the classification Skin Corrosive 1 and Eye Damage 1 is proposed for the test chemical.