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Administrative data

Description of key information

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:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not reported
Specific details on test material used for the study:
Name: Saturn Grey LCGCAS: 31765-95-4Batch No.: 8010/2008Appearance: black powderStorage: dark dry room, closed container, at laboratory temperatureExpiration date: February 2018
Species:
guinea pig
Strain:
other: BFA
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: monitored breeding farm (RČH CZ 21760039, Luboš Sobota, U nádraží 901, Městec Králové, Czech Republic)- Females (if applicable) nulliparous and non-pregnant: yes- Age at study initiation: not listed- Weight at study initiation: 295 - 453 g- Housing: monitored conditions, microbiologically defined background, shavings of soft wood- Diet (e.g. ad libitum): pelleted standard diet for guinea pigs ad libitum- Water (e.g. ad libitum): drinking tap water ad libitum (supplemented by ascorbic acid)- Acclimation period: 5 days- Indication of any skin lesions: no signs of disease were observed at clinical check-inENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3°C (permanently monitored)- Humidity (%): 30 - 70 %- Photoperiod (hrs dark / hrs light): 12 hrs light/dark cycle
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Induction – intradermal injections: 10% suspension in physiological salineInduction – topical application: 10% suspension in physiological salineChallenge – topical application: 5% suspension in physiological saline
Day(s)/duration:
Day 0 - inntradermal injection Day 6 - topical application
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
5 % (w/w)
Day(s)/duration:
20th day
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 animals (M+F) in treatment group (10 animals (M+F) in control group)
Details on study design:
DOSE LEVELS: - Induction – intradermal injections: 10% suspension in physiological saline - Induction – topical application: 10% suspension in physiological saline - Challenge – topical application: 5% suspension in physiological salineAPPLICATION:Day 0, treated group:Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region which was cleared of hair so that one of each pair lies on each side of midline. - Injection 1: 1:1 (v/v) mixture Freunds Complete Adjuvant (FCA) and physiological saline - Injection 2: 10% suspension of the test substance in physiological saline - Injection 3: 10% suspension of the test substance in 1:1 1 (v/v) mixture FCA / physiological salineDay 0, control group:Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region which was cleared of hair so that one of each pair lies on each side of midline. - Injection 1: 1:1 (v/v) mixture Freunds Complete Adjuvant (FCA) and physiological saline - Injection 2: 10% physiological saline - Injection 3: 10% physiological saline in 1:1 1 (v/v) mixture FCA / physiological salineDay 6, treated group:24 hours before application (day 5) the test area was cleared of hair. A filter paper (2×4 cm) with 10% suspension of the test substance in physiological saline was applied to the test area and held in contact by an occlusive dressing for 48 hours.Day 6, control group:24 hours before application (day 5) the test area was cleared of hair. A filter paper (2×4 cm) with physiological saline only was applied in a similar manner to the test area and held in contact by an occlusive dressing for 48 hours.Day 20, treated and control group:The flanks of treated and control animals were cleared of hair before application. In treated and control animals a filter paper (2×2 cm) saturated with 5% suspension of the test substance in physiological saline was applied on a right flank of the animals and a filter paper (2×2 cm) with physiological saline only was applied on a left flank of the animals. The patches were hold in contact by an occlusive dressing for 24 hours.Day 22–23, treated and control group:Approximately 21 hours after removing patch the challenge area were cleaned and shaved. Approximately 3 hours later (cca 48 hours from the start of application of the challenge application) the skin reaction were observed and recorded according to the Magnusson and Kligmann grading scale. Approximately 24 hours after this observation a second observation (72 hours) were made and skin reaction was again recorded.MAGNUSSON AND KLIGMAN GRADING SCALE 0 = no visible change 1 = discrete or patchy erythema 2 = moderate and confluent erythema 3 = intense erythema and swellingOBSERVATION - Skin reaction: 24, 48, 72 and 96 hours after intradermal injection, 48,72 and 96 hours after induction – topical application, 48 and 72 hours after challenge - Clinical signs of intoxication and health condition: daily - Mortality/viability: daily - Body Weight: 0 and 24th day
Challenge controls:
MAGNUSSON AND KLIGMAN GRADING SCALE 0 = no visible change 1 = discrete or patchy erythema 2 = moderate and confluent erythema 3 = intense erythema and swelling
Positive control substance(s):
yes
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 % (w/w)
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
discrete erythema without another clinical manifestation
Remarks on result:
not measured/tested
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5 % (w/w)
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
discrete erythema without another clinical manifestation
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
without clinical changes
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
without clinical changes
Remarks on result:
no indication of skin sensitisation

Body weight of the animals throughout the experiment (average values):

Treated group (20 animals):

- Start of study: 384 g

- End of study: 563 g

- Increment: 179 g

Control group (10 animals):

- Start of study: 324 g

- End of study: 487 g

- Increment: 163 g

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The test substance, Direct Black 112, caused a positives skin reaction in 6 of 20 animals, i.e. in 30 % of animals which were exposed to the test substance. The exposed animals showed no other negative clinical symptoms throughout the experiment.The body weight of animals increased though the study and it was not affected by the treatment. In the course of experiment the animals did not show any clinical symptoms of intoxication.The test substance, Direct Black 112, was shown to be a contact allergen in guinea pigs.
Executive summary:

The test substance, Direct Black 112, was tested for the assessment of skin allergic effects using albino guinea pigs.

The test was performed according to the EU Method B.6 Skin sensitisation. The method is analogous to the OECD Test Guideline No. 406 Skin Sensitisation. The Magnusson and Kligman maximization procedure was followed. The pilot experiment was implemented on 3 animals. The main test was performed on 20 treated and 10 control animals.

The experiment proceeded in three phases: two induction phases (intradermal injections and topical application) and the challenge phase. Potential skin reactions were evaluated at the end of experiment.

The evaluation of skin reactions in the exposed group carried out at 48 hours after the start of the challenge phase showed discrete erythema in 1 animal. Evaluation at 72 hours after the start of the challenge phase of study showed discrete erythema in next 5 animals. No other negative clinical symptoms through the experiment were recorded.

The test substance, Direct Black 112, caused a positives skin reaction in 6 of 20 animals, i.e. in 30 % of animals which were exposed to the test substance. The exposed animals showed no other negative clinical symptoms throughout the experiment.

The body weight of animals increased though the study and it was not affected by the treatment. In the course of experiment the animals did not show any clinical symptoms of intoxication.

The test substance, Direct Black 112, was shown to be a contact allergen in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with GPMT skin sensitisation test result and pursuant to the classification rules declared in Regulation (EC) No. 1272/2008, the test substance, Direct Black 112, is classified as Skin Sens. 1B.