Benzaldehyde

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: No guideline followed. Non-GLP. Only secondary source. Only short notice.

Data source

Reference

Reference Type:

secondary source

Title:

No information

Author:

Klecak, G. et al., J., cited in German MAK documentation 1998

Year:

1977

Bibliographic source:

J. Soc. Cosmet. Chem. 28, 53-64 (1977)

Materials and methods

Principles of method if other than guideline:

Methods specified as Draize test (DT), Mazimization Test (MT) and Intradermal Test with Freund's complete adjuvant (FCAT).

GLP compliance:

not specified

Type of study:

other: Maximization test

Test material

Test material information

Constituent 1

Reference substance name:

Benzaldehyde

EC Number:

202-860-4

EC Name:

Benzaldehyde

Cas Number:

100-52-7

Molecular formula:

C7H6O

IUPAC Name:

benzaldehyde

In vivo test system

Test animals

Species:

guinea pig

Results and discussion

Any other information on results incl. tables

Positive, but incompletely documented results were obtained in a study with benzaldehyde in the Draize Test, 
maximization test and FCA test with male and female guinea pigs (Himalayan white-spotted). In the Draize Test 
the animals were treated once intradermally with 0.05 mL and on nine subsequent days with 0.1 mL of a 0.1% 
preparation of benzaldehyde (in total 0.95 mg/animal) in isotonic saline. Provocation was carried out on days 35 
and 49 by intradermal injection of 0.05 mL of the 0.1 % preparation. The test protocol of the maximization test 
corresponded more or less with the standard conditions: intradermal induction with 5 % benzaldehyde 
(in total 20 mg, vehicle not specified), epicutaneous induction by means of 48 -hour occlusive treatment with
a moderately irritative preparationof 25 % benzaldehyde (250 mg) in petroleum, provocation on day 21 with a 
non-irritative concentration in petrolatum (24 h, occlusive, no further details).In the FCA test, induction was 
carried out by 5 injections in the necks of the animals on days 0, 2, 4, 7 and 9 of 0.05 mL (in total about 250 mg) 
ofthe undiluted substance spiked with the same amount of FCA, and provocation on days 21 and 35 with a 
non-irritative concentration in petrolatum (24 h,occlusive, no further details). Control animals were treated 
intradermally with FCA only (Klecak et al., 1977).

In summary, the reported test result was negative for the Open Epicutaneous Test (OT) and positive for the Draize Test,
Mazimization Test and Intradermal Test with Freund's complete adjuvant. Thus, a skin sensitizing potential can be presumed, 
based on theat information.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information

Conclusions:

Based on the results of the above cited study, and due to the presence of a structural alert for protein binding (aldehyde group), a skin sensitization potential of benzaldehyde appears likely. Thus, benzaldehyde is classified skin sens. Cat.1 and R43 according to Regulation (EU) 1272/2008 and EU Directive 67/548/EEC, respectively.