Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)

Endpoint summary

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Standard guideline study; GLP

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

other: CBA/J

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River France
- Age at study initiation: ca 8 weeks
- Weight at study initiation: 19 - 24 g
- Housing: Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad ibitum
- Acclimation period: > 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25 C
- Humidity (%): 30 to 50 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

0 - 10 - 25 - 50 %

No. of animals per dose:

3

Details on study design:

TREATMENT PREPARATION AND ADMINISTRATION:
Animals were anesthetized by inhalation of isoflurane. The test material was applied to the back of the ears at a volume of 25µL per ear of the respective preparation. Administration was perform once a day for three consecutive days. The control animals were treated accordingly using the vehicle only.

Parameter:

SI

Remarks on result:

other: S.I. Control - 10 % 0,72 25 % 0,68 50 % 0,49

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: DPM/group No. of nodes DPM/node Control 2317,05 10 225,86 10 % 1677,95 10 161,95 25 % 1583,91 10 152,55 50 % 1163,53 10 110,51

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item showed no indication of a skinn sensitizing potential in the local lymph node assay in mice.

Executive summary:

After treatment of four groups of female CBA/J mice with the test item in acetone/olive oil (4/1) topically on the back of the ears on three consecutive days no proliferation of the draining lymph nodes was recorded as shown by a lack of increased incorporation of 3H-Thymidine in lymph node cells. The volume applied was 25 µL and the concentrations were 10 , 25, and 50 %. The stimulation index varied between 0,72 and 0,49.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

After treatment of four groups of female CBA/J mice with the test item in acetone/olive oil (4/1) topically on the back of the ears on three consecutive days no proliferation of the draining lymph nodes was recorded as shown by a lack of increased incorporation of 3H-Thymidine in lymph node cells. The volume applied was 25 µL and the concentrations were 10 , 25, and 50 %.The stimulation index varied between 0,72 and 0,49. The limit for positive effects was not reached. The test item was judged as non sensitising.

This conclusion was also confirmed by a Maximisation test on an structurally similar analoguous substance.

Migrated from Short description of key information:
After treatment of four groups of female CBA/J mice with the test item in acetone/olive oil (4/1) topically on the back of the ears on three consecutive days no proliferation of the draining lymph nodes was recorded as shown by a lack of increased incorporation of 3H-Thymidine in lymph node cells. The volume applied was 25 µL and the concentrations were 10 , 25, and 50 %. The stimulation index varied between 0,72 and 0,49.

Justification for selection of skin sensitisation endpoint:
recent guideline study under GLP, target substance tested,

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No classification; Based on the negative result of the LLNA test no skin senstisation potential is expected.