Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 June 2010 - 7 July 2010
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to official EC and OECD test guidelines, and in compliance with GLP.
according to
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
according to
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
other: CBA/Ca
Details on test animals and environmental conditions:
- Source: UK
- Age at study initiation: Eight to twelve weeks
- Weight at study initiation: 16.8 to 20.8 g
- Housing: Animals were housed individually in polycarbonate cages with woodflake bedding. The mice were also given Nestlets and a plastic shelter for environmental enrichment. Each animal was assigned an alpha-numeric code and identified uniquely within the study by tail marking. Each cage label was colour-coded and was identified uniquely with the study number, dose level and animal mark.
- Diet (e.g. ad libitum):The animals had access to a standard rodent diet. This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
- Water (e.g. ad libitum): Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.
- Acclimation period: at least 5 days

- Temperature (°C): 19 to 23
- Humidity (%): 40 to 70
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours continuous dark per 24 hours.

acetone/olive oil (4:1 v/v)
0, 25, 50 and 100% w/v
No. of animals per dose:
Details on study design:
- Name of test method: The local lymph node assay
- Criteria used to consider a positive response: The test substance is regarded as a sensitizer if at least one concentration of the chemical results in a three-fold greater increase in 3HTdR incorporation compared to control values.

TREATMENT PREPARATION AND ADMINISTRATION: The mice were treated by daily application of 25 μl of each of one of these three concentrations, or control, to the dorsal surface of both ears for three consecutive days.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
This positive control study is considered to be valid if the results from the hexyl cinnamic aldehyde (HCA) group have a three-fold greater increase in 3HTdR incorporation compared to control values.
In this assay the test/control ratios obtained for HCA at 10, 25 and 50% v/v were 2.3, 7.7 and 13.1. This indicates that Hexyl cinnamic aldehyde demonstrates the potential to induce skin sensitization (delayed contact hypersensitivity) and confirms the sensitivity.
Remarks on result:
other: Test / control ratios: Group 2 (25%w/v) = 0.7 Group 3 (50% w/v) = 0.5 Group 4 (100% w/v) = 0.8
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Group no: Concentration (% w/v) dpm 1 AOO 4786.95 2 25 3565.65 3 50 2594.25 4 100 3968.35 dpm Disintegrations per minute (less background count of 44.15 dpm) AOO Acetone:olive oil (4:1 v/v) (vehicle control)

There were no deaths and no signs of ill health or toxicity observed during this study, however the following observations were noted:

Greasy fur was noted for all control and test animals post-dose from Day 1 for control animals and from Day 3 for all test animals. This sign had resolved completely in all animals by Day 5.

Black dose residue on ears was noted for all test animals post-dose on Day 1. Wet fur was also noted for all test animals post-dose on Day 1. These signs had resolved completely in all animals by Day 4.

Interpretation of results:
not sensitising
Migrated information Criteria used for interpretation of results: EU
Ferrophosphorus (Fe3P) is not regarded as a potential skin sensitizer.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A Local Lymph Node Assay (Huntingdon Life Sciences, 2010) was conducted to assess the potential for Fe3P to cause skin sensitization. The study was conducted according to OECD test guideline 429 and EC guideline B42, and in compliance with GLP.

Test groups of four mice per concentration were administered daily applications of 25 µL of vehicle (acetone : olive oil, 4:1 (v/v)), 25%, 50%, or100% w/v Fe3P in vehicle to the dorsal surface of both ears for three consecutive days. The proliferative response of the lymph node cells was then assessed five days after the initial application. Test control ratios (ratio of the proliferative response seen in test groups relative to the control group) were 0.7, 0.5, and 0.8 for the 25%, 50%, and 100% groups, respectively, and on this basis Fe3P is not considered to be a potential sensitizer.

Migrated from Short description of key information:
Local Lymph Node Assay: Not sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The Local Lymph Node Assay (LLNA, Huntingdon Life Sciences, 2010) conducted on Fe3P concluded that it was not a potential sensitizer. On this basis, it may be stated conclusively that Fe3P should not be classified as a dermal sensitizer under either the CLP Regulation (1272/2008) or the Dangerous Substances Directive (67/548/EEC).