Registration Dossier
Registration Dossier
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EC number: 605-460-1 | CAS number: 167004-78-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 1995. OECD 429 guideline (LLNA) was adopted in 2002.
Test material
- Reference substance name:
- Phosphinic acid, P-[3-(acetyloxy)-3-cyanopropyl]-P-methyl-, butyl ester
- EC Number:
- 605-460-1
- Cas Number:
- 167004-78-6
- Molecular formula:
- C11 H20 N O4 P
- IUPAC Name:
- Phosphinic acid, P-[3-(acetyloxy)-3-cyanopropyl]-P-methyl-, butyl ester
- Details on test material:
- Molecular weight: 261 g/mol
Molecular formular: C11H2ONO4P
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Hoe 125869; substance, technical, Identification No. C00083/01
- Purity, including information on contaminants, isomers, etc.: 88.4% (w/w)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness -20°C (freezer)
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: 4 hours, confirmed by analysis
- Storage stability: 6 months at -10°C ±5°C
- Appearance: yellow, viscous liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hoe, DHPK (SPFLac)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Weight at study initiation: 295 g (average)
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
- Diet (e.g. ad libitum): ssniff® Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs light): 12 hours daily
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL test substance was applied to a 2x4 cm celulose patch. Dermal induction and challenge treatment were carried out with 100 % (undiluted) test substance.
- Route:
- intradermal
- Vehicle:
- other: isotonic saline
- Concentration / amount:
- Two intradermal injections per animal (2x 0.1mL). The treatment group was performed with 1.0 % [w/v] test substance in isotonic saline.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: isotonic saline
- Concentration / amount:
- treatment group was performed with 1.0 % [w/v] test substance in isotonic saline. Dermal induction and challenge treatment were carried out with 100 % (undiluted) test substance.
- No. of animals per dose:
- The following test groups were used for the study:
Determination of primary non-irritant concentration: 6 animals
Determination of the tolerance of intradermal injections: 5 animals
Escort group*: 5 animals
Control group: 10 animals
Treatment group: 20 animals
* used to rule out effects (lowering of primary non-irritant concentration) by Freund's Complete Adjuvant - Positive control substance(s):
- yes
- Remarks:
- dinitrochlorbenzene (DNCB) for the BUEHLER test and nickel sulfate for the Magnusson-Kligman test at intervals of approximately 6 months.
Results and discussion
- Positive control results:
- The validity of the test system is confirmed in positive control tests using nickel sulfate for the Magnusson-Kligman test at intervals of approximately 6 months. In these studies the positive control substane gave the expected positive response.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st challenge and 2nd challenge
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical observations
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- Erythema Scores: 8 score 1; 3 score 2; no oedema observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: Erythema Scores: 8 score 1; 3 score 2; no oedema observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- No oedema were observed. Erythema scores: four animals score 1 and two animals with score 2.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- No oedema were observed. Erythema scores: 11 animals score 1, two animals score 2
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- Erythema Scores: 7 core 1; 2 score 2; no oedema observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: Erythema Scores: 7 core 1; 2 score 2; no oedema observed.
Any other information on results incl. tables
There were no clinical signs of intoxication. The body weight gain of the animals was not impaired. After challenge treatment, very slight to well-defined erythema were observed in thirteen of twenty animals of the treatment group. No signs of irritation occurred in the control animals after challenge treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the conditions of the present study, thirteen of twenty animals of the treatment group showed a positive skin response after the challenge procedure. Based on the results of this study, the test substance is sensitizing and thus subject to labelling requirements. Classification according to CLP (EG) No. 1272/2008 as skin sensitizing Cat. 1 (H317) is warranted.
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