Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Hazard via inhalation route

In accordance with the column 2 adaptation of column 1, REACH Annex VIII, the acute dermal toxicity study (required in section 8.5.2) is not considered scientifically justified as the oral and dermal exposure routes are the most appropriate to assess the acute toxicity hazard presented by the substance based on its physico-chemical characteristics and use pattern.

Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the inhalation route does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.

Hazard via dermal route

In accordance with the criteria for classification as defined in the annex I of the Regulation 1272/2008/EC, the test material does not meet the criteria for classification for acute dermal toxicity. Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the dermal route does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.

Skin irritation: As Acacia Mearnsi did not induce any skin irritation effects, it does not need to be classified according to classification of Reg. 1272/2008/EC

Hazard via oral route

In accordance with the criteria for classification as defined in the annex I of the Regulation 1272/2008/EC, the test material does not meet the criteria for classification for acute oral toxicity.

The repeated dose administration of the Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde according to the 422 OECD guidance, to Wistar rats at different dosages revealed neither mortalities nor findings of toxicological relevance in animals. Based on these results, according to the 1272/2008/EC the substance shouldn't need to be classified.

Hazard to the eyes

Due to the irritation Index and the reversibility of the irritation observed after 14 days (Study report from Eunice Mayumi Suenaga, 1998), Acacia Mearnsi is classified as Eye irritant Cat. 2 according to classification criteria of 1272/2008/EC.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Hazard via inhalation route

In accordance with the column 2 adaptation of column 1, REACH Annex VIII, the acute dermal toxicity study (required in section 8.5.2) is not considered scientifically justified as the oral and dermal exposure routes are the most appropriate to assess the acute toxicity hazard presented by the substance based on its physico-chemical characteristics and use pattern.

Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the inhalation route does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.

Hazard via dermal route

In accordance with the criteria for classification as defined in the annex I of the Regulation 1272/2008/EC, the test material does not meet the criteria for classification for acute dermal toxicity.Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the dermal route does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.

Skin irritation: As Acacia Mearnsi did not induce any skin irritation effects, it does not need to be classified according to classification of Reg. 1272/2008/EC

Hazard via oral route

In accordance with the criteria for classification as defined in the annex I of the Regulation 1272/2008/EC, the test material does not meet the criteria for classification for acute oral toxicity.

The repeated dose administration of the Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde according to the 422 OECD guidance, to Wistar rats at different dosages revealed neither mortalities nor findings of toxicological relevance in animals. Based on these results, according to the 1272/2008/EC the substance shouldn't need to be classified.

Hazard to the eyes

Due to the irritation Index and the reversibility of the irritation observed after 14 days (Study report from Eunice Mayumi Suenaga, 1998), Acacia Mearnsi is classified as Eye irritant Cat. 2 according to classification criteria of 1272/2008/EC.