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Description of key information

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0). The studies are as mentioned below:

 

The peer reviewed journal conducted skin sensitization study for read across chemicals in albino guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. In this test, for the induction phase, the left flanks of 10 albino guinea pigs were shaved and the each test material were applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the each test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different concentration (10.0%, 5.0%, and 2.50%of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase.  No erythema/edema was observed after 24 and 48 hours post-application. Hence the test chemical was considered as not sensitizing to the guinea pigs’ skin.

 

The above result was further supported by another experimental study conducted by same peer reviewed journal for another similar read across chemical. The study was followed by the same method as per mentioned in above study in albino guinea pigs. Since no erythema/edema was observed after 24 and 48 hours post-application, the test chemical was considered as not sensitizing to the guinea pigs’ skin.

 

Based on the above summarized studies for target chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization of test chemical was determined by performing a modified Buehler and Klecak method on guinea pigs.
GLP compliance:
not specified
Type of study:
other: a modified Buehler and Klecak method
Justification for non-LLNA method:
not specified
Specific details on test material used for the study:
- Name of test material : Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone
- Substance type : Organic
- Physical state : Solid
Species:
guinea pig
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
other: 1.epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
10% (0.1mL)
Day(s)/duration:
3 weeks
Adequacy of induction:
not specified
Route:
other: 1.epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
10.0%, 5.0%, and 2.50%
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hour
- Test groups: 10
- Control group: no data
- Site: shaved left flanks of ten albino guinea pigs over a 1.8-cm circular area.
- Frequency of applications: three times weekly (Monday, Wednesday Friday) for three consecutive weeks.
- Duration: 3 weeks
- Concentrations:10%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Two week rest period
- Exposure period: 24 hours
- Test groups: 10
- Control group:
- Site: shaved left flanks of ten albino guinea pigs
- Concentrations: 10.0%, 5.0%, and 2.50%
- Evaluation (hr after challenge): 24 hour and 48 hours
Positive control substance(s):
yes
Remarks:
0.5% DNCB
Reading:
other: 1-2.1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10.0%, 5.0%, and 2.50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No erythema/edema was observed after 24 and 48 hours post-application
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
No erythema/edema was observed after 24 and 48 hours post-application

All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale

 0 = no reaction,

 1 = slight reaction,

2 = moderate reaction and

3 = severe reaction.

A positive reaction was defined as an erythema/edema

value during the challenge phase of at least one skin grade higher than during the last induction phase

Interpretation of results:
other: not sensitizing
Conclusions:
The test material Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) was considered to be not sensitizing to the skin.
Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0). The studies are as mentioned below:

 

The peer reviewed journal conducted skin sensitization study for read across chemicals in albino guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. In this test, for the induction phase, the left flanks of 10 albino guinea pigs were shaved and the each test material were applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the each test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different concentration (10.0%, 5.0%, and 2.50%of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase.  No erythema/edema was observed after 24 and 48 hours post-application. Hence the test chemical was considered as not sensitizing to the guinea pigs’ skin.

 

The above result was further supported by another experimental study conducted by same peer reviewed journal for another similar read across chemical. The study was followed by the same method as per mentioned in above study in albino guinea pigs. Since no erythema/edema was observed after 24 and 48 hours post-application, the test chemical was considered as not sensitizing to the guinea pigs’ skin.

 

Based on the above summarized studies for target chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0). The studies are as mentioned below:

 

The peer reviewed journal conducted skin sensitization study for read across chemicals in albino guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. In this test, for the induction phase, the left flanks of 10 albino guinea pigs were shaved and the each test material were applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the each test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different concentration (10.0%, 5.0%, and 2.50%of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase.  No erythema/edema was observed after 24 and 48 hours post-application. Hence the test chemical was considered as not sensitizing to the guinea pigs’ skin.

 

The above result was further supported by another experimental study conducted by same peer reviewed journal for another similar read across chemical. The study was followed by the same method as per mentioned in above study in albino guinea pigs. Since no erythema/edema was observed after 24 and 48 hours post-application, the test chemical was considered as not sensitizing to the guinea pigs’ skin.

 

Based on the above summarized studies for target chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.