Registration Dossier
Registration Dossier
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EC number: 265-111-0 | CAS number: 64742-11-6 A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
Endpoint summary
Administrative data
Description of key information
Key skin (similar to 404) and eye (OECD 405) irritation studies were identified.
Although valid in its methodology, the skin irritation assay differs from the current OECD guidelines in that animals were exposed under occluded conditions for 24 hours instead of semi-occluded conditions for 4 hours. Considering the conditions of the test, results must be interpreted carefully for the purposes of classification and labelling. The mean scores for erythema and oedema have been assessed against the deviations, and provided the test would be conducted under standard conditions, slight irritation might be expected but insufficient to classify.
For eye irritation, the test material was found to be not irritating in the eyes of rabbits.
A number of supporting studies are available showing that the material is not classified as irritating to the skin and eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A key skin irritation study was identified. In this study, white rabbits (6 male) were dermally exposed to 0.5 mL of light paraffinic distillate solvent extract for 24 hours to both an intact skin site and abraded skin site (API, 1986a). Animals then were observed for 14 days. Irritation was scored by the method of Draize (1959). The mean (24 and 72 hour, intact skin) erythema and oedema scores were 2.45 and 2.5, respectively.
Although this test is valid in its methodology, it differs from the current OECD guidelines in that animals were exposed under occluded conditions for 24 hours instead of semi-occluded conditions for 4 hours. Considering the conditions of the test, results must be interpreted carefully for the purposes of classification and labelling. The mean scores for erythema and oedema have been assessed against the deviations, and provided the test would be conducted under standard conditions, slight irritation might be expected but insufficient to classify.
It is concluded therefore that distillate aromatic extracts are not skin irritants, but may cause defatting and skin dryness. Hence R66 (EUH066) is appropriate for all DAEs. This is also supported by repeated dose studies.
One key eye irritation study was identified. In this study, 0.1 mL of undiluted light paraffinic distillate solvent extract was instilled into the conjunctival sac of one eye of 9 white rabbits. Group I animal eyes remained unwashed, while Group II animal eyes were flushed with water for 1 minute, 20 to 30 seconds after instillation. Animals then were observed for 7 days. Irritation was scored by the method of Draize (1959).
The mean cornea, iris, conjuctivae scores (24 to 72 hours) were 0.0, 0.0, and 0.44, respectively. Results from this study indicate that DAEs are not eye irritants. The test material is classified as not irritating to the eye according to EU criteria.
Additional data supports that DAE is not a skin (ARCO, 1973d; ARCO, 1982e; ARCO, 1984g, h; ARCO, 1985d; Food and Drug Research Laboratories, 1974d) or eye (ARCO, 1973b; ARCO, 1982b; ARCO, 1984j, k, l, m; and Food and Drug Research Laboratories, 1974c) irritant. This information is presented in the dossier.
Justification for selection of skin irritation / corrosion endpoint:
one of seven studies showing similar results
Justification for selection of eye irritation endpoint:
one of seven studies showing similar results
Justification for classification or non-classification
Distillate aromatic extracts do not meet the criteria for classification as skin or eye irritants as according to the criteria of the EU CLP Regulation (EC No. 1272/2008).
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