Blue MGi 1037-Na (notification presscake)

Endpoint summary

Description of key information

The read across substance Blue MGi 1037, a structural analogue of the target substance, does not cause skin sensitisation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 June 2000 - 14 July 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Directive 96/54/EEC, B.6 Maximisation test

Version / remarks:

1996

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The OECD TG 429 was first adopted in 2002.

Species:

guinea pig

Strain:

other: Ibm:GOHI

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Switzerland
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals: SPF
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 310 - 420 g
- Housing: individually in Makrolon type-4 cages
- Diet: ad libitum, pelleted standard Nafag Ecosan 845 25 W4 guinea pig breeding/maintenance diet, containing Vitamin C
- Water: ad libitum, tap water
- Acclimation period: 1 week
- Indication of any skin lesions: no

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 23
- Humidity (%): 37-64
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Route:

intradermal

Vehicle:

water

Concentration / amount:

10%

Day(s)/duration:

Day 1

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

50%

Day(s)/duration:

Day 8/ 48 hours

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

10%

Day(s)/duration:

Day 22/24h

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

Number of animals in test group: 10
Number of animals in negative control group: 5

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three pairs of intradermal injections (0.1 mL per site)
- Test groups:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test item, at 10 % in bi-distillcd water.
3) The test item at 10 % in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Control group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline
2) Bi-distilled water
3) 1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.

- Site: dorsal skin from scapular region

B. INDUCTION EXPOSURE
- No. of exposures: one epidermal application/occlusive
One week after the injections, the scapular area (approximately 6x8 cm) was again clipped and shaved free of hair prior to the application. A 2 x 4 cm patch of filter paper was saturated with the test item (50 % in bi-distilled water) and placed over the injection sites of the test animals. The volume of test item preparation applied was approximately 0.3 mL. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The occlusive dressings were left in place for 48 hours. The epidermal application procedure described ensures intensive contact of the test item.
The guinea pigs of the control group were treated as described above with bi-distilled water only, also applied at a volume of approximately 0.3 mL.The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
- Test groups: 10%
- Control group: bi-distilled water
- Site: left and right flank
- Evaluation (hr after challenge): 24 and 48 hours after removal of the bandage

Positive control substance(s):

no

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10 %

No. with + reactions:

0

Total no. in group:

10

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

10 %

No. with + reactions:

0

Total no. in group:

10

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Total no. in group:

5

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0%

No. with + reactions:

0

Total no. in group:

5

Reading:

other:

Group:

positive control

Dose level:

-

Remarks on result:

not measured/tested

Maximum concentration not causing irritating effects in preliminary test: 10 %

Signs of irritation during induction:
Test group:
No animals showed oedema after induction. As the test item at 50 % stained the skin blue, it was not possible to determine whether erythema was present or not.

Control group:
No animals showed oedema or or erythema after induction.

Evidence of sensitisation of each challenge concentration:
10 % concentration: 0/10 (10 %) of tested animals showed sensibilisation.

Other observations:
MORALITY:
There were no deaths during the course of the study.

CLINICAL SIGNS:
No signs of systemic toxicity were observed in the animals.

BODY WEIGHT:
The body weight was within the range.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance Blue MGi 1037, a structural analogue of the target substance, does not cause skin sensitisation.

Executive summary:

In order to assess the cutaneous allergenic potential of BLUE MGi 1037, the Maximization- Test was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.

The intradermal induction of sensitization in the test group was performed in the nuchal region with a 10 % dilution of the test item in bi-distilled water and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50 % in bi-distilled water one week after the intradermal induction. The animals of the control group were intradermally induced with bi-distilled water and FCA/physioIogical saline and epidermally induced with bi-distilled water under occlusion.

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10 % in bi-distilled water and bi-distilled water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

None of the control and test animals showed skin reactions after the challenge treatment with BLUE MGi 1037 at 10 % (w/w) in bi-distilled water.

Based on the findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 96/54/EECT BLUE MGi 1037 has not to be classified and labelled as a skin sensitizer.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In order to assess the cutaneous allergenic potential of the structural analogue BLUE MGi 1037, the Maximization- Test was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.

The intradermal induction of sensitization in the test group was performed in the nuchal region with a 10 % dilution of the test item in bi-distilled water and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50 % in bi-distilled water one week after the intradermal induction. The animals of the control group were intradermally induced with bi-distilled water and FCA/physioIogical saline and epidermally induced with bi-distilled water under occlusion.

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10 % in bi-distilled water and bi-distilled water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

None of the control and test animals showed skin reactions after the challenge treatment with BLUE MGi 1037 at 10 % (w/w) in bi-distilled water.

Based on the findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 96/54/EECT BLUE MGi 1037 has not to be classified and labelled as a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this information, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.