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EC number: 235-397-1 | CAS number: 12217-38-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- May 26, 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available
Test material
- Reference substance name:
- Acid Yellow 061 - Similar Substance 01
- IUPAC Name:
- Acid Yellow 061 - Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN Gartenstr. 27, D-33178 Borchen, SPF breeding colony
- Females (if applicable) nulliparous and non-pregnant: not specified
- Weight at study initiation: mean = 364 g
- Housing: macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff® Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at Ieast 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light daily
- Animai identification: fur marking with KMnO4 and cage numbering
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100 % of test substance moistened with 0.8 mi deionized water
- Day(s)/duration:
- Day 1 to 15
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100 % of test substance moistened with 0.8 ml deionized water
- Day(s)/duration:
- day 29
- No. of animals per dose:
- 20 in the test group
10 in the control group
3 in the primary non-irritant concentration test group - Details on study design:
- RANGE FINDING TESTS:
In a dermal-occlusive test for primary skin irritation, each of the following test concen-trations was administered to the flank of two guinea pigs:
100.0 % Telon-Gelb GW Micro 20.0 % in deionized water 4.0 % in deionized water
The hair on the flank of the animals was removed mechanically. 0.5 g of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 6 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema according to the scale of the EEC-Guideline B.6.
MAIN STUDY
A. INDUCTION EXPOSURE
Day 1 to 15
During this test phase, the following procedures were carried out once a week. For the dermal treatments, 100 % Telon-Gelb GW Micro moistened with 0.8 ml deionized water was administered in evenly over a 2 x 2 cm cellulose patch, which was fixed to the front part of the left flank of the 20 animals of the treatment group and then covered with an occlusive polyethylene film and a bandage (Fixomull). The 10 contrai animals were treated analogously with 0.5 ml of the vehicle. After an exposure period of 6 hours the occlusive bandage was removed and the flank skin washed. Clinical signs and irritant effects emerging during the sensitization phase were recorded.
Days 16 to 28
No further animai treatment.
Animals under observation (weekends excepted).
B. CHALLENGE EXPOSURE
Day 29
Challenge treatment. This took piace under identical conditions for control and treated animals alike. The hair of the previously untreated right flank was removed mechanically. Challenge treatment was performed with 100 % Telon-Gelb GW Micro moistened with 0.8 ml deionized water. 0.5 g of the test concentration was administered to a 2 x 2 cm cellulose patch, which was placed on the hind part of the right flank and covered with an occlusive bandage. - Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- Based on the results of this study alpha-hexyl cinnamic aldehyde may cause sensitization by skin contact. The test system used in this study proved to be suitable for the determination of dermal sensitizer.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 % of test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 % of test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
Determination of the primary non-irritant concentration
The skin surface of the animals was discolored light yellow but no signs of irritation occurred after administration of the different test concentrations.
Based on these resuits, 100 % of test substance was selected for the sensitization treatments.
Body weight gains and clinical signs
The body weight gains of the animais were not impaired. The treated animals showed no clinical signs of intoxication throughout the study.
Irritations during the sensitization phase
The skin surface of the animals was discolored light yellow in the treatment group during the sensitization phase. The animais of the control group showed no signs of irritation.
Dermal challenge treatment
The skin surface of the animals was discolored tight yellow in the control and the treatment group 24 and 48 hours after removal of the occlusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not skin sensitizer
- Executive summary:
Method
Testing for the sensitizing properties of the tested substance was performed in female guinea pigs according to the method of BUEHLER (OECD guideline 406).
Dermal induction was performed using 100 % of the test substance moistened with 0.8 ml of deionized water. The control group was exposed to deionized water only. Challenge treatment was carried out with 100 % of test substance moistened with 0.8 ml of deionized water.
The validity of the test system is confirmed by the periodically conducted positive contral test using alpha-hexyl cinnamic aldehyde for the BUEHLER test.
Results
Under the conditions of the present study, none of twenty animais of the treatment group showed a positive skin response after the challenge procedure. Thus, the percentage of animals reacting positive is below the threshold of 15 %.
Based on the results of this study the test substance showed no evidence for sensitizing properties.
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