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Administrative data

Description of key information

Key study: Read-across from experimental data on an analogue.Test method OECD Guideline 429. GLP study. The test item was determined to be not-sensitizing to the skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimisch 1) is available.
Reason / purpose:
read-across source
No. of animals per dose:
up
Key result
Parameter:
EC3
Remarks on result:
not determinable
Remarks:
Stimulation indices of 2.55, 1.63 and 2.22 were determined with the analogue substance at concentrations of 2.5, 5 and 10 % in dimethylsulfoxide. The EC3 value (concentration of test item required to produce a S.I of 3) could not be calculated, since none of the tested concentrations induced an S.I greater than 3.
Parameter:
SI
Value:
2.55
Test group / Remarks:
2.5 %
Remarks on result:
other: Based on the read-across from an analogue substance.
Parameter:
SI
Value:
1.63
Test group / Remarks:
5 %
Remarks on result:
other: Based on the read-across from an analogue substance.
Parameter:
SI
Value:
2.22
Test group / Remarks:
10 %
Remarks on result:
other: Based on the read-across from an analogue substance.
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA
2.5%: DPM = 8589.9 (1073.7 DMP per lymph node)
5%: DPM = 5490.5 (686.3 DMP per lymph node)
10%: DPM = 7505.11 (7484.8 DMP per lymph node)

EC3 CALCULATION
The EC3 Value could not be calculated, since all SI´s are below 3.

CLINICAL OBSERVATIONS:
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.

BODY WEIGHTS
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Interpretation of results:
GHS criteria not met
Remarks:
CLP Implementation.
Conclusions:
Based on the read-across approach, P-1401 was determined to be non-skin sensitizer in the Local Lymph Node Assay.
Executive summary:

A Local Lymph Node Assay was performed with the analogue substance P0310 for assessing its possible contact allergenic potential, according to OECD guideline 429 and following GLP. For this purpose a local lymph node assay was performed using test item concentrations of 2.5, 5 and 10% dissolved in dimethylsulfoxide. Four groups of four female CBA/CaOlaHsd mice received topically the three different doses and a positive control respectively. Five days after they received 20.1 μCi 3HTdR/mouse, by intravenous injection. The animals were examined for clinical signs, body weight and viability/mortality. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I) of 2.55, 1.63 and 2.22 were determined with the test item at concentrations of 2.5, 5 and 10% dimethylsulfoxide, respectively. Based on these results, the read-across approach was applied and the test item P-1401 was determined not to be a skin sensitizer.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization: Read-across approach from experimental data on the analogue substance P0310:

Key study: A Local Lymph Node Assay test was performed in mice with the analogue substance P0310 in accordance with OECD 429 (GLP study). In this study Stimulation Indices (S.I) of 2.55, 1.63 and 2.22 were determined with the test item at concentrations of 2.5, 5 and 10% dimethylsulfoxide, respectively. The substance was determined as not a skin sensitizer under the test conditions.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on available data, the substance is not classified for skin sensitization according to CLP Regulation (EC) No. 1272/2008.