Reaction mass of sodium amino-bis{[4-(ethenylsubstituted)phenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-{[4-(ethenylsubstituted)phenyl]diazenyl}-{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-bis{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate

Endpoint summary

Description of key information

The test item FAT 40865/A TE was found to be a skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Principles of method if other than guideline:

Guidelines followed

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Specific details on test material used for the study:

None

Species:

mouse

Strain:

other: CBA/CaOlaHsd

Sex:

female

Details on test animals and environmental conditions:

Test system: Mice, CBA/CaOlaHsd
Rationale: Recognised as the recommended test system.
Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
Number of animals for pre-test: 5 females (2 for the 1st and 2nd pre-test, each, and 1 for the 3rd pre-test)
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1

Age (at beginning of treatment):
1st pre-test: 10 - 11 weeks
2nd pre-test and main study: 9 - 10 weeks
3rd pre-test: 8 - 9 weeks

Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
Acclimation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.


The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
Housing: group
Cage Type: Makrolon Type II (pre-test) / III (main study), with wire mesh top
Bedding: granulated soft wood bedding
Feed: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
Water: tap water, ad libitum
Environment: temperature 22 + 2°C, relative humidity approx. 45-65%, artificial light 6.00 a.m. - 6.00 p.m.

Vehicle:

dimethylformamide

Remarks:

Purity: 99%

Concentration:

0, 2, 5, 10 % (w/w)

No. of animals per dose:

4

Details on study design:

Not available

Positive control substance(s):

other: α hexyl cinnamaldehyde dissolved in acetone/olive oil (4+1, v/v)

Statistics:

Not available

Positive control results:

None

Key result

Parameter:

SI

Remarks on result:

other: Test item concentration / S.I. 0 / 1.00 2 /8.61 5 / 8.47 10 / 8.89

Key result

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Test item concentration / Measurement DPM / DPM per lymph node 0 / 4680 / 582.9 2 / 40169 / 5019.1 5 / 39539 / 4940.3 10 / 41477 / 5182.6

Viability / Mortality

No deaths occurred during the study period.

Clinical Signs

No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period. Redness of the ear skin could not be detected, due to the colour of the test item.

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:

Category 1 (skin sensitising) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test item FAT 40865/A TE was found to be a skin sensitiser under the test conditions of this study.

Executive summary:

An OECD Guideline 429 (local lymp node) assay was performed in accordance to GLP to assess for possible skin sensitising potential of test item FAT 40865/A.The test item was formulated in DMF at concentrations of 2, 5, and 10% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by three pre-experiments. The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. Redness of the ear skin could not be observed, due to the colour of the test item. In this study Stimulation Indices (S.I.) of 8.61, 8.47, and 8.89 were determined with the test item at concentrations of 2, 5, and 10% (w/w) in DMF, respectively. A clear dose response was not observed. However, all SI's clearly exceeded the threshold value of 3. The test item FAT 40865/A TE was found to be a skin sensitiser.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

An OECD Guideline 429 (local lymp node) assay was performed in accordance to GLP to assess for possible skin sensitising potentialof test item FAT 40865/A.The test item was formulated in DMF at concentrations of 2, 5, and 10% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by three pre-experiments. The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. Redness of the ear skin could not be observed, due to the colour of the test item. In this study Stimulation Indices (S.I.) of 8.61, 8.47, and 8.89 were determined with the test item at concentrations of 2, 5, and 10% (w/w) in DMF, respectively. A clear dose response was not observed. However, all SI's clearly exceeded the threshold value of 3. The test item FAT 40865/A TE was found to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test item FAT 40865/A TE was found to be a skin sensitiser under the test conditions of this study. Hence, classified as skin sensitiser 1 according to CLP (Regulation 1272/2008) criteria.