Registration Dossier

Administrative data

Description of key information

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

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:
Weight of evidence approach based on test chemicals
Justification for type of information:
Weight of evidence approach based on test chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on test chemicals
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on test chemicals
Justification for non-LLNA method:
No data available
Species:
guinea pig
Strain:
other: 1.Pirbright albino 2.albino
Sex:
male/female
Details on test animals and environmental conditions:
No data available
Route:
other: 1.epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
4%
Day(s)/duration:
6h hours
Adequacy of induction:
not specified
Route:
other: 1.intradermal
Vehicle:
other: 0.75% saline in deionised water
Concentration / amount:
0.1%
Day(s)/duration:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
other: epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1%
Day(s)/duration:
6 hours
Adequacy of challenge:
not specified
No.:
#2
Route:
other: intradermal
Vehicle:
other: 0.75% saline in deionised water
Concentration / amount:
0.1%
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
1.Total :
46 Preliminary study: 6 animals
2.20 Main study- Treated group:30
Control group:102.
Positive control substance(s):
not specified
Reading:
other: 1. 1st reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
30
Clinical observations:
No skin sensitization reaction was observed
Remarks on result:
no indication of skin sensitisation
Reading:
other: 2. 1st reading
Group:
test group
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
No skin sensitization reaction was observed (8 animals died due to not particularly healthy.)
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not Sensitizing
Conclusions:
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Executive summary:

The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

Buehler test was performed using 30 female Pirbright albino guinea pigs in treated group and 10 in control group to assess the dermal sensitization potential of the test chemical. Doses were selected on the bases of preliminary study using 6 animals.In induction phase, induction given on day 1, using 4 % concentration inwaterby topical application as2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and removed afterwards. The second induction given on day 8 and third on day 15 using same procedure on day first. During the induction phase, the skin sites wereexamined for local effects 24 hours after each treatment. In challenge phase, on day 29 test substance 1% concentration in same vehicle appliedon a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hour and evaluated 24 and 48hr after removal of occlusive dressing .All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.No skin sensitizing reaction observed after challenge applicationalso no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight to well-defined erythema and very slight oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group.Hence the test chemicalwas considered to be not skin sensitizing in guinea pig.

The above result was further supported by the another sensitization study using Intracutaneous method in 20male albino guinea pigs. During induction phase, the animals were treated intradermally at concentration of 0.1 % in 0.75% saline in deionised water by using 8 applications. After 3 weeks, the animals were challenged at the same concentration used in induction phase. No skin sensitizing reactions were observed after challenge application while 8 animals died as they were not particularly healthy. Since the death observed were not substance related, the test chemical was considered to be not sensitizing to the skin.

 

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

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

The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

Buehler test was performed using 30 female Pirbright albino guinea pigs in treated group and 10 in control group to assess the dermal sensitization potential of the test chemical. Doses were selected on the bases of preliminary study using 6 animals. In induction phase, induction given on day 1, using 4 % concentration in water by topical application as2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and removed afterwards. The second induction was given on day 8 and third on day 15 using same procedure on day first. During the induction phase, the skin sites were examined for local effects 24 hours after each treatment. In challenge phase, on day 29 test substance 1% concentration in same vehicle appliedon a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hour and evaluated 24 and 48hr after removal of occlusive dressing .All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.No skin sensitizing reaction observed after challenge applicationalso no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight to well-defined erythema and very slight oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group.Hence the test chemical was considered to be not skin sensitizing in guinea pig.

The above result was further supported by the another sensitization study using Intracutaneous method in 20male albino guinea pigs. During induction phase, the animals were treated intradermally at concentration of 0.1 % in 0.75% saline in deionised water by using 8 applications. After 3 weeks, the animals were challenged at the same concentration used in induction phase. No skin sensitizing reactions were observed after challenge application while 8 animals died as they were not particularly healthy. Since the death observed were not substance related, the test chemical was considered to be not sensitizing to the skin.

 

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

 Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.