Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Most sensitive endpoint:
irritation (respiratory tract)

Workers - Hazard for the eyes

Additional information - workers

Acute oral toxicity

 

Five male rats were gavaged with a single dose of the test material at dose levels of 215, 464, 1000 and 2150 mg/kg bw and observed for 14 days. At the 2150 mg/kg bw dose level,all rats were found dead six hours after dosing. At all levels the test substance caused the rats to become depressed and irritable. At dose levels of 464 and 1000 mg/kg bw, 2 out of 5 rats died. The acute oral LD50 in the rat was calculated to be 791 (467 -1350) mg/kg bw, which is consistent woth the currnet classifation (R22).

 

Acute dermal toxicity

 

The test substance was applied for 24 hours under occlusive conditions at dose levels of 1000, 2150, 4540 and 10000 mg/kg bw. Animals were observed for 14 days. At the 4640 mg/kg bw dose level the rabbits were observed to be moderately depressed after exposure to the test substance. At the 1000 and 2150 mg/kg bw dose levels, rabbits had mild to moderate necrosis at the application site, except for one rabbit at the 1000 mg/kg bw dose level, which was free from irritation. At the 454 mg/kg bw dose level, one rabbit had slight oedema and the remaining three had oedema, necrosis and severe erythema. At a dose level of 1000 mg/kg and 2150 mg/kg there were no mortalities. At dose levels of 4640 and 10000 mg/kg bw, there was 100% mortality. The acute dermal LD50 of the test substance was calculated to be 3160 mg/kg bw

Irritation and corrosion

The substance is classified as highly flammable and reacts with moisture to liberate a toxic gas; no testing for skin or eye irritation is therefore proposed. The results of an acute dermal toxicity study in rabbits show irritant effects at the application site.

The results of an older published study of skin irritation (500 mg/24 h application) and eye irritation (20 mg/24 h application) cited in the ECB IUCLID 4 summary and in RTECS indicate that the substance is a moderate skin irritant and a moderate eye irritant. However the original reference cannot be located.

Based on the findings of the acute dermal toxicity study, considering the liberation of phosphoric acid resulting from the degradation of the substance in contact with water and based on the results of older studies, classification of the substance as a skin and eye irritant (R36/38) is considered to be appropriate. No further testing is proposed, for reasons of animal welfare.

Genotoxicity

Negative Ames tests are available for the degradataion products hydrogen sulphide and phosphoric acid.

DNEL derivation

Insufficient data on repeated exposure are available for the derivation of a DNEL according to REACH guidance. The effects of the substance are predicted to be predominantly limited to local toxicity (irritation/corrosion) at the site of contact. Due to the nature of the substance, exposure should be minimised by the use of containment and protective equipment. However OEL values are available in EU Member States and are presented here. Values of 1 mg/m3 and 2 mg/m3 for long-term (8 -hour TWA) and short-term (15 -minute STEL) values are cited in EH40/2005 Workplace Exposure Limits (UK HSE) and are considered to be adequately protective for local (respiratory tract) irritation.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The substance is classed as a transported isolated intermediate. No exposure of the general population is proposed and DNEL values are not derived.