Registration Dossier
Registration Dossier
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EC number: 203-699-2 | CAS number: 109-73-9
Endpoint summary
Administrative data
Description of key information
No sensitising potential was observed in two in-vivo studies in guinea-pigs (GPMT, Buehler). The GPMT served as key study, the Buehler test as supporting information.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No LLNA test has been performed as a reliable non-LLNA skin sensitising assay has already been available.
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley HOE DHPK [SPF-LACJ
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Germany
- Age at study initiation: young adults
- Weight at study initiation: 301 - 350 g
- Housing: 5 animals in Makrolon, type IV cages
- Diet: Kliba Labordiaet 341, ad libitum
- Water: tap water ad libitum (about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 5%
Intradermal induction: test substance 0.1%
Percutaneous induction: test substance 5% in aqua bidest. - Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- Challenge: test substance 2% in aqua bidest.
- No. of animals per dose:
- Control group: 10
Test group: 20 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 intradermal injections in groups of two per animal and one percutaneous exposure 1 week after intradermal induction.
- Exposure period: percutaneous exposure: 48 h
- Test groups: 12 animals
- Control group: 6 animals
- Site: shoulder
B. CHALLENGE EXPOSURE
- No. of exposures: single percutaneous exposure
- Day(s) of challenge: 24 h
- Site: intact flank
- Concentrations: 2x2 cm filter paper strips containing the test substance.
- Evaluation (hr after challenge): 24 h and 48 h after removal of the patch. - Positive control substance(s):
- yes
- Remarks:
- Performed in a separate study twice a year in the laboratory with 1-Chloro-2,4-dinitrobenzene
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythema and edema.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the test item was not sensitising.
- Executive summary:
In a guinea pig maximisation test according to OECD guideline 406 the animals (20 in test group, 10 controls) were subjected to 6 intradermal induction treatments with 0.1% test substance in aqua bidest, or 0.1% in Freund's adjuvant/aqua bidest (1:1) or Freund's adjuvant/aqua bidest (1:1) without test substance. Percutaneous induction was performed 1 week after the last induction with 5% test substance in aqua bidest. The animals were challenged with 2% in aqua bidest. and skin reaction examined 24 and 48 h after treatment. No positive reactions were observed.
Reference
Maximization Test:
Challenge Test group:
Form of application: right flank: 2% in aqua bidest.
| Animal No. | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | ||
| Findings 24 h after removal of the patch | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | ||
| Findings 48 h after removal of the patch | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | ||
Erythema/Edema
After the intradermal induction with 5% test substance preparations well-defined erythema and slight edema were observed at the injection sites of the control group animals and test group animals at which only Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) was applied. Injection of the test substance preparation in 0.9% aqueous NaCl-solution caused necrotic skin changes in addition to slight edema in few injection sites and well-defined erythema and very slight edema in almost all injection sites of the animals of the test group. Necrotic skin changes and slight edema or well defined erythema and slight edema could be observed after application of the test substance preparation in Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1) in the test group animals.
The control group animals which were treated with 0.9% aqueous NaCl-solution did not show any skin reactions.
After the percutaneous induction with a 5% test substance preperations necrotic skin changes, partially open (caused by the intradermal induction) in addition to slight edema could be observed.
The challenge with the 2% test substance preparations in aqua bidest. did not cause any skin reaction in all animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitising properties of the substance have been investigated in two reliable in vivo assays (Buehler and GPMT). In the key study (GPMT) guinea pigs were induced with 0.1% or 5% test item, epidermal challenge was performed with a 2% dilution. None of the animals treated with the test item showed skin sensitising effects (BASF, 1993). Negative results were also obtained in a Buehler Assay (Pennwalt, 1988).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no data requirement for investigating skin sensitising effects of substances with corrosive properties. However, the existing studies have already been performed before the REACH-Regulation came into force and therefore provide additional information beyond the REACH data requirements.
Justification for classification or non-classification
Due to the negative findings in two in vivo assays no classification for skin sensitisation has to be performed according to the Regulation (EC) No 1272/2008.
However, according to REACH Annex VII section 8.3 column 2 skin sensitisation studies (in vitro and in vivo) do not need to be conducted if the substance is classified as skin corrosion or is a strong base. Since both criteria are fulfilled, no additional studies are required.
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