Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-479-6 | CAS number: 107-29-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, according to OECD test guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Adopted May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- September 1984
- GLP compliance:
- yes
- Remarks:
- US FDA (21 CFR 58) and US EPA (40 CFR 160 and 40 CFR 792)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Acetaldehyde oxime
- EC Number:
- 203-479-6
- EC Name:
- Acetaldehyde oxime
- Cas Number:
- 107-29-9
- Molecular formula:
- C2H5NO
- IUPAC Name:
- acetaldehyde oxime
- Details on test material:
- -Commercial name/code: AAX/310588
-Chemical name: Acetaldoxime
-Appearance: colourless liquid
-Batch No.: T109-AAX422
-Storage: at room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfield, FRG
- Age at study initiation: approximately 2 months
- Weight at study initiation: 361-510 g
- Housing: metal cages with wire-mesh floors
- Diet: standard guinea pig diet, including ascorbic acid (1600 mg/kg) obtained from Hope Farms, Woerden (LC 23-B, pellet diameter 4 mm), in addition hay was provided once a week
- Water: ad libitum
- A combined quarantine/acclimatisation period of 14 days was allowed (7 days for the animals of the primary irritation experiment)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 60-90
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiological saline; physiological saline emulsified with an equal volume of Freunds Complete Adjuvant; Milli-RO water
- Concentration / amount:
- induction:
-intradermal injections: 0.5%
-epicutaneous application: 25%
challenge:
- first: 0, 10, 25, 50%
- second: 0, 10, 20, 40%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiological saline; physiological saline emulsified with an equal volume of Freunds Complete Adjuvant; Milli-RO water
- Concentration / amount:
- induction:
-intradermal injections: 0.5%
-epicutaneous application: 25%
challenge:
- first: 0, 10, 25, 50%
- second: 0, 10, 20, 40%
- No. of animals per dose:
- test group: 20
control: 10 - Details on study design:
- RANGE FINDING TESTS:
Primary irritation experiments included intracutaneous injections and
epicutaneous applications of several concentrations of the test
substance diluted in Milli-RO water (Millipore Corp., Bedford, Mass,.
USA). One animal received 4 x 0.1 mI intracutaneous injections of 5%
(w/w) test substance and the undiluted test substance epicutaneously
applied. This animaI was found dead the next day. An extra animaI
was added and received 4 x 0.1 mI intracutaneous injections of 1%
(w/w) test substance and 0.5 mI 50% (w/w) concentrations
epicutaneously applied. The intracutaneous injections caused redness.
The epicutaneous application caused slight redness and scaliness of
the skin. This animal showed Iethargy, a pale skin and diarree the
days after treatment. Because of this, the test substance
concentration for the first induction was decreased to 0.5% (w/w).
Af ter cancelling the first Guinea Pig Maximization Test on study day 8
(because of mortality and systemic toxicity) an extra preliminary test was performed. For controling the
dermal toxicity of the test substance a second extra animal was
added, which received 0.5 mI 50% (w/w) test substance in Milli-RO
water. Also this animal showed the same signs of toxicity as the
animal before, therefore the test substance concentration for the
second induction was decreased to 25% (w/w). Four other animals
received an epicutaneous application of the test substance at 100%,
50%, 25% and 5% (w/w) in an amount of 0.05 mI using Square chambers
(v.d. Bend, Brielle, the Netherlands).
No signs of systemic toxicity were observed in these four treated
animaIs, except a slight bodyweight loss of the first animal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 h (epicutaneous application)
- Test groups:
intradermal injection: test substance (0.5% w/w in physiological saline); Freunds Complete Adjuvant (FCA) emulsified with an equal volume of distilled water; test substance (1.0% w/w in physiological saline) emulsified with an equal volume of FCA
epicutaneous application: test substance
- Control group:
intradermal injection: physiological saline; FCA; FCA emulsified with an equal volume of physiological saline
epicutaneous application: water
- Site: between the shoulders
- Concentrations:
intradermal injection: 0.5 and 1% w/w
epicutaneous application: 25% w/w
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21, 28
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: left flank (day 21), right flank (day 28)
- Concentrations:
first challenge: 50, 25, 10, 0%
second challenge: 40, 20, 10, 0%
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde solution
Results and discussion
- Positive control results:
- A positive control experiment was carried out in September 1987 (NOTOX 0000/809) in order to validate the animals and the test procedure.
Test substance: formaldehyde solution 37% (p.a., art. 4003, Merck, Darmstadt, FRG)
Induction phase: 5% (V/V) in Milli-RO water (Millipore Corp., Bedford, Mass., USA).
Challenge phase: 5%, 3% and 0.5% (V/V) in Milli-RO water.
A sensitization rate of 100 per cent was obtained to the 5%, 3% and 0.5% concentrations.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0, 10, 25, 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0, 10, 25, 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0, 10, 25, 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0, 10, 25, 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0, 10, 20, 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0, 10, 20, 40%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0, 10, 20, 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0, 10, 20, 40%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0, 10, 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0, 10, 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0, 10, 25, 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0, 10, 25, 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0, 10, 20, 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0, 10, 20, 40%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0, 10, 20, 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0, 10, 20, 40%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
INDUCTION
Eleven experimental animals showed severe erythema to eschar formation on the treated skin after removal of the dressings from the second induction. This was mainly a combined result of the intracutaneous injection and the epicutaneous application.
CHALLENGE
The test substance was diluted in Milli-RO water to three concentrations (50%, 25% and 10%) and administered epicutaneously to guinea pigs in the challenge phase. This challenge treatment produced positive skin reactions (grade 2 or more) in one experimental animal in reaction to the 50% test substance concentration. Nine other
experimental animals and two control animals showed red spots in reaction to one or two concentrations tested. Therefore, a second challenge was performed 7 days later with the following test substance cocncentrations: 40%, 20% and 10% (w/w).
None of the experimental animals showed a positive response in reaction to the concentrations tested. Five experimental animals showed red spots in reaction to one or two of the concentrations tested.
No skin reactions were observed in the control animals to any of the application sites, except for one animal 48 h after
removal of the dressings. No consistent signs of systemic toxicity were observed in any of the animals during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: 67/548/EEC
- Conclusions:
- The results lead to a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.
- Executive summary:
A sample of AAX/310588 was tested in the Guinea Pig Maximization
Test (Magnusson and Kligman) to determine its sensitizing
potential.
Adult female guinea pigs (Dunkin-Hartley strain) were induced by
intradermal injections of the test substance, 0.5% (w/w) in
physiological saline, followed by epicutaneous application of a
25% solution of the test compound in Milli-RO water. After being
challenged with three test substance concentrations in Milli-RO
water, 50%, 25% and 10% (w/w), one experimental anima1 showed a
positive response (grade 2) in reaction to the 50% concentration.
Nine other experimental animals and two control animals showed
red spots in reaction the one or two of the concentrations tested.
Due to this unclear reaction, a second challenge was
performed 7 days later, with the following concentrations: 40%,
20% and 10% (w/w). None of the experimental animals showed a
positive response in reaction to this second challenge treatment.
Five experimental animals and one control animal showed red spots
in reaction to one or two of the concentrations tested.
Thus, a sensitization rate of 0 per cent was obtained. Therefore
it is improbable that the test substance has sensitizing
properties.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
