Acrylaldehyde

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Acrolein has been the subject of a risk assessment carried out under Community Regulation (EEC) No 793/93 (EU, 2001). The key information on skin sensitisation by acrolein as stated is a quotation taken from this EU Risk Assessment.There is only one study available on the skin sensitization potential of acrolein (Susten and Breitenstein, 1990). The interpretation of this study within the EU Risk Assesement and further assessments carried out under other international and national programmes published after finalisation of the EU Risk Assessment Report 2001 (World Health Organization, International Programme on Chemical Safety (IPCS), Concise International Chemical Assessment Document of Acrolein, CICADS 43 (WHO, 2002); United States Environmental Protection Agency, Toxicological Review of Acrolein (US-EPA, 2003); United States Agency for Toxic Substances and Desease Registry, Toxicological Profile for Acrolein (US ATSDR, 2007); United States Environmental Protection Agency, HED Risk Assessment for Reregistration Eligibility Decision (RED) Document for Acrolein (US-EPA, 2008)) is inconsistent. Here the interpretation of this study as given in the EU Risk assessment Report, 2001 is followed:

1. European Union Risk Assessment Report of Acrolein (EU, 2001)

“Acrolein is reported to be negative in the guinea pig maximisation test (Susten and Breitenstein, 1990). In this study female guinea pigs were treated with acrolein in water. The concentrations used for the intradermal and topical induction phases and for the topical challenge phase were 0.01%, 2.5% and 0.5%, respectively. DNCB in ethanol 70% was used as positive control. The study was poorly reported, but the raw data of this study were submitted by industry on request. Skin reactions were scored on a scale 0.5, 1, 2 and 3. Challenge treatment induced skin reactions in a maximum of 7 test animals (score 0.5), whereas only one control animal showed the same score. The distinguishment between score 0.5 and 1 is not made in the OECD-guidelines. According to the authors score 0.5 is defined as patches of redness, not confluent, and score 1 as mild redness, confluent. Given this description and the description in the OECD-guidelines (score 1: discrete or patchy erythema) score 0.5 should be interpreted as score 1 according to OECD. Since the incidence of skin reactions was much higher in test animals than in control animals it seems dubious to conclude that the test substance is not a skin sensitizer. However, no definite conclusion with respect to the sensitisation potential can be made on the basis of the present study.“

“There are no other sensitisation studies available.”

“There are no human data available on sensitising properties of acrolein.”

“The sensitisation study available is not performed and reported according to GLP requirements. However, given the results observed acrolein could be considered as a skin sensitizer and labelling with R43 is indicated. The Classification and labelling according to the Council Directive 67/548/EEC came to the conclusion not to classify for sensitisation.” quotations from EU, 2001, p61

2. Agreement with further International Reports and Studies Published after Finalisation of the EU Risk Assessment Report 2001

No, there are disagreements in the interpretation of the only available study on the skin sensitisation potential of acrolein Susten and Breitenstein, 1990.

3. Substantial Disagreements in Comparison to further International Reports to European Union Risk Assessment Report 2001

WHO, 2002 judges the study Susten and Breitenstein, 1990 as inadequate to allow an assessment of the potential of acrolein to induce sensitization: “Although results of the only relevant study identified (i.e., a guinea-pig maximization test reported by Susten and Breitenstein, 1990) were suggestive, due to limitations in the protocol and reporting of results, available data are considered inadequate to allow an assessment of the potential of acrolein to induce sensitization.” quotation from WHO, 2002, p23

US-EPA, 2003 disagrees in the evaluation of the only known study on skin sensitisation (Susten and Breitenstein, 1990) with the EU Risk assessment Report, 2001 and follows the original interpretation of the study results by the study authors as negative: “Topical administration of acrolein to the shaved skin of female guinea pigs (15) was shown not to result in positive skin reactions; positive controls were used (Susten and Breitenstein, 1990).” quotation from US-EPA, 2003, p40

In US ATSDR, 2007, the study Susten and Breitenstein, 1990 on the skin sensitization potential of acrolein is not cited.

In US-EPA, 2008, the result of the study Susten and Breitenstein, 1990 on the skin sensitization potential of acrolein is not mentioned. However in Final Reregistration Eligibility Decision (RED) Document for Acrolein ListB Case No. 2005 (September 2008) (US-EPA, 2008b) the study is judged as “suggestive/limited data”. quotation from US-EPA, 2008b, p12

4. Additional Aspects in further International Reports

None

5. Additional Information in Newer Studies, not Included in the European Union Risk Assessment Report 2001 or further Cited International Reports

None

Migrated from Short description of key information:
“The sensitisation study available is not performed and reported according to GLP requirements. However, given the results observed acrolein could be considered as a skin sensitizer and labelling with R43 is indicated. The Classification and labelling according to the Council Directive 67/548/EEC came to the conclusion not to classify for sensitisation.” quotation from European Union Risk Assessment Report Acrylaldehyde (EU, 2001)

Justification for selection of skin sensitisation endpoint:
see European Union Risk Assessment Report of Acrolein (EU, 2001)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Acrolein has been the subject of a risk assessment carried out under Community Regulation (EEC) No 793/93 (EU, 2001). The key information on respiratory sensitisation by acrolein as stated is a quotation taken from this EU Risk Assessment. Experimental study data on respiratory sensitisation are lacking. However, in the EU Risk Assessment a reasoning on respiratory sensitisation in reference to thr entire toxicity data on the substance has been made:

1. European Union Risk Assessment Report of Acrolein (EU, 2001)

“There are neither data from human experience nor from other sources indicating respiratory sensitisation.” quotation from EU, 2001, p85

2. Agreement with further International Reports and Studies Published after Finalisation of the EU Risk Assessment Report 2001

not applicable: There is no information on respiratory sensitisation in further international reports and studies published after finalisation of the EU Risk Assessment Report 2001

3. Substantial Disagreements in Comparison to further International Reports to European Union Risk Assessment Report 2001

not applicable: There is no information on respiratory sensitisation in further international reports and studies published after finalisation of the EU Risk Assessment Report 2001

4. Additional Aspects in further International Reports

None

5. Additional Information in Newer Studies, not Included in the European Union Risk Assessment Report 2001 or further Cited International Reports

None

Migrated from Short description of key information:
“There are neither data from human experience nor from other sources indicating respiratory sensitisation.” quotation from European Union Risk Assessment Report Acrylaldehyde (EU, 2001)

Justification for selection of respiratory sensitisation endpoint:
see European Union Risk Assessment Report of Acrolein (EU, 2001)

Justification for classification or non-classification

There in no clear evidence on intrinsic sensitising activity of acrolein. Acrolein has been the subject of a risk assessment carried out under Community Regulation (EEC) No 793/93 (EU, 2001). This assessment came to the following conclusion: “The sensitisation study available is not performed and reported according to GLP requirements. However, given the results observed acrolein could be considered as a skin sensitizer and labelling with R43 is indicated. The Classification and labelling according to the Council Directive 67/548/EEC came to the conclusion not to classify for sensitisation.” quotation from EU, 2001, p61.

In the meantime since finalisation of the EU Risk Assessment, no further data on the sensitising activity of acrolein came up.

In agreement with Regulation (EC) No 1907/2006, Annex VII 8.3, column 2 further in vivo testing does not need to be conducted, because the available information indicates that the substance should be classified for corrosivity. Moreover, the substance is flammable at room temperature.

Thus, in accordance to the conclusion of the risk assessment carried out under Community Regulation (EEC) No 793/93 (EU, 2001), acrolein does no have to be classified as a skin sensitiser. Since the criteria for classification as skin sensitiser on the basis of animal studies as outlined in Council Directive 67/548/EWG Annex VI, 3.2.7.2 are identically to the criteria outlined in Regulation (EC)1272/2008, 3.4.2.2.4.1, acrolein does not have to be classified as skin sensitiser according to Regulation (EC)1272/2008 either.