Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin sensitisation (in vivo; GPMT); Not sensitising (OECD 406)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: SNIF
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12-year rule, this is data not owned by the registrant. The reliability is assumed to be at level 2. Therefore the following reliability statement can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incorect reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
All information in this endpoint has been provided by the ECHA using the 12-year rule.
Species:
guinea pig
Strain:
other: Hartley/Dunkin
Sex:
female
Route:
intradermal
Vehicle:
other: liquid paraffin
Concentration / amount:
1%
Day(s)/duration:
Day 0
Adequacy of induction:
other: no irritation noted
Route:
other: dermal
Vehicle:
other: liquid paraffin
Concentration / amount:
50%
Day(s)/duration:
Day 7
Adequacy of induction:
other: no irritation noted
No.:
#1
Route:
other: not stated
Vehicle:
other: liquid paraffin
Concentration / amount:
25%
Day(s)/duration:
48 hrs
Adequacy of challenge:
not specified
No.:
#2
Route:
other: not stated
Vehicle:
other: liquid paraffin
Concentration / amount:
50%
Day(s)/duration:
48 hrs
Adequacy of challenge:
not specified
No. of animals per dose:
20 test group
20 controls
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
4
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
2
Total no. in group:
19
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
4
Total no. in group:
19

Other observations:

In a preliminary study, dermal application at 10-50% w/w in liquid paraffin did not cause any skin reactions. At challenge only slight erythema was seen in all animals that showed a skin reaction; scores in test animals did not exceed those in controls. One control animal died prior to challenge (death not treatment-related).

Interpretation of results:
GHS criteria not met
Conclusions:
In an in vivo skin sensitisation (GPMT), the substance is not sensitising.
Executive summary:

In a dermal sensitization study (OECD 406) with DL-N33 in paraffin oil, Hartley/Dunkin female guinea pigs were tested in a maximisation test. For induction, 1% DL-N33 in paraffin oil (intradermal injections) and 50% DL-N33 in paraffin oil (dermal) was used. For challenge, 25% and 50% DL-N33 in paraffin oil was used. The evaluation of skin reactions after challenge was carried out at 48 hrs.

In the preliminary study, dermal application at 10-50% w/w in liquid paraffin did not cause any skin reactions. One control animal died prior to challenge in the main study (death not treatment-related). In the main study at 25%, 4/20 test group animals and 2/19 control animals were positive. At 50%, 5/20 test group animals and 4/19 control animals were positive. At challenge, only slight erythema was seen in all animals that showed a skin reaction. The substance is not sensitising.

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

There is no in vitro skin sensitisation data available. One in vivo skin sensitisation (GPMT) is available.

In a dermal sensitization study (OECD 406) with DL-N33 in paraffin oil, Hartley/Dunkin female guinea pigs were tested in a maximisation test. For induction, 1% DL-N33 in paraffin oil (intradermal injections) and 50% DL-N33 in paraffin oil (dermal) was used. For challenge, 25% and 50% DL-N33 in paraffin oil was used. The evaluation of skin reactions after challenge was carried out at 48 hrs. No positive control substance was used. In a preliminary study, dermal application at 10-50% w/w in liquid paraffin did not cause any skin reactions. One control animal died prior to challenge in the main study (death not treatment-related). In the main study at 25%, 4/20 test group animals and 2/19 control animals were positive. At 50%, 5/20 test group animals and 4/19 control animals were positive. At challenge, only slight erythema was seen in all animals that showed a skin reaction. The substance is not sensitising.

The data is acceptable to use in the human health risk assessment.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information in the dossier, the substance DL-N33 (CAS No. 104815-18-1) does not need to be classified for skin sensitisation when the criteria outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied.