Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key acute oral (similar to OECD 401), dermal (similar to OECD 402), and inhalation (OECD 403)  toxicity studies (OECD 420) were identified.

• The oral LD50 was > 5000 mg/kg bw in male and female rats for light paraffinic DAE.

• The inhalation LC50 was > 5 mg/L for DAE.

• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for light paraffinic DAE.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
one of seven studies showing similar results.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5 000 mg/m³ air
Quality of whole database:
two studies availble that give the same results

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
one of seven studies showing similar results.

Additional information

Key oral, dermal, and inhalation toxicity studies were identified for distillate aromatic extracts.

Acute Oral Toxicity

In an acute oral toxicity study, groups of fasted, 7 week old Sprague-Dawley rats (5/sex) were given a single oral dose of undiluted light paraffinic distillate solvent at a dose of 5000 mg/kg body weight (API, 1986). Animals were observed for 14 days. Clinical signs observed included: hypoactivity, ataxia, red stained face, yellow-stained anal area, diarrhoea, and oily haircoat. All animals had returned to normal within 8 days of test material administration. The oral LD50 was determined to be greater than 5000 mg/kg body weight in males and females.

Acute Inhalation Toxicity

In an acute inhalation toxicity study, groups of young adult Sprague Dawley rats (5/sex) were exposed by inhalation route to distillate aromatic extract (aerosol) for 4 hours to whole body at a concentrations of 5.0 mg/L (ARCO, 1983a). Animals then were observed for 14 days. All animals were lethargic during the last 2 hours of exposure. From hour 2 of treatment until the first hour post-exposure, animals kept their eyes partially closed and were lacrimating. One rat displayed red nasal discharge following exposure and red ocular discharge. Another rat exhibited yellow eye discharge during the fourth hour post-exposure and red eye discharge the morning following treatment until the end of the third day post-treatment. These findings are considered related to treatment. Three rats of each sex showed pallor and/or swelling of the kidneys. These findings may be related to treatment. The acute aerosol LD50 of distillate aromatic extract is greater than 5.0 mg/L of air. 

Acute Dermal Toxicity

In an acute dermal toxicity study, groups of New Zealand White rabbits (8/sex) were dermally exposed to undiluted light paraffinic distillate solvent extract for 24 hours to 10% of total body area at doses of 2000 and 3000 mg/kg bw (API, 1986). Animals then were observed for 14 days. At the 2000mg/kg bw dosage level: diarrhoea, dyspnoea, hypoactivity, prostration, emaciation, soft stool. At the 3000mg/kg bw dosage level: no signs of systemic toxicity (or mortality). Dermal irritation was observed and ranged from slight to severe for erythema and oedema. The dermal LD50 was determined to be greater than 3000 mg/kg body weight in both males and females.

Additional data supports that DAE is not an acute oral (ARCO, 1973c; ARCO, 1982a; ARCO, 1983b, c, d, e; ARCO, 1985b; , inhalation (ARCO, 1983e), or dermal (ARCO, 1973a; ARCO, 1982d; ARCO, 1984b, c, d; ARCO, 1985a;) toxicant. This information is presented in the dossier.

Justification for selection of acute toxicity – oral endpoint

one of 7 acute oral toxicity studies showing LD50 values > 5000 mg/kg

Justification for selection of acute toxicity – inhalation endpoint

one of 2 studies giving  similar results

Justification for selection of acute toxicity – dermal endpoint

one of 7 acute oral toxicity studies showing LD50 values > 2000 mg/kg

Justification for classification or non-classification

Based on evaluation of all the acute toxicity data discussed above, DAE does not meet the criteria for classification as an acute oral, inhalation or dermal toxicant under the EU CLP Regulation (EC No. 1272/2008).