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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Based on experimental data with a read-across substance (CAS 102 -06 -7) the test item is considered to be not skin sensitizing.

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:
key study
Justification for type of information:
The test item (target substances, CAS 24245-27-0) is the salt of 1,3-diphenylguanidine and mono-hydrochloride. As read-across source substance the uncharged free base of 1,3-diphenylguanidine (CAS 102-06-7) is applied. This is considered appropriate since the target substance is expected to readily dissociate in contact with water such as surface water in the environment or the intestinal fluids or mucosal membranes of an organism. 1,3-diphenylguanidine is considered a weak base. Therefore, it is expected to be present as uncharged molecule at neutral and high pH solutions. However, acidic conditions will lead to protonation of the molecule and the charged ion is expected to be the main present form. Since transformation of the target to the source substance and vice versa is anticipated, kinetics and toxicological behaviour are well transferable from the source to the target substance. This applies for human health endpoints as well as for the aquatic environment.
Moreover, chloride ions are ubiquitously present in every-day nutrition and are part of numerous physiological processes. Therefore, this constituent does not require further assessment in regards to its toxicological behaviour. It is expected to be well regulated by endogenous physiological mechanisms of the organism.
Based on the considerations above, a read-across is considered appropriate and further tests, especially vertebrate studies, are not needed to adequately address this endpoint. Information Requirements are fulfilled according to REACH Annex XI Section 1.5.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 mL of a 25 % solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 mL of a 25 % solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5 mL of a 0.5 % solution
No. with + reactions:
5
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5 mL of a 0.5 % solution
No. with + reactions:
5
Total no. in group:
5
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Read-across approach:

There are no experimental data available regarding skin sensitizing properties of the test item. However, data are available with a structural analogues substance (CAS 102 -06 -7) which are suitable and adequate to fulfill this endpoint. For Read-across justification please refer to the respective IUCLID Section.

in vivo GPMT

The potential of the read-across substance to induce delayed contact hypersensitivity following intradermal injection and cutaneous application was evaluated in guinea-pigs according to the maximization method of Magnusson and Kligman. The study was conducted in compliance with the Principles of Good Laboratory Practice Regulations. Fifteen guinea-pigs were allocated to two groups: a control group of 5 females, and a treated group of 10 females. The sensitization potential of DPG was evaluated after a 10 -day induction period during which time the animals were treated with paraffin oil (control group) or DPG (treated group). On day 1, in presence of freud's complete adjuvant, 0.1 mL of the test substance at a concentration of 1 % (w/w) in the vehicle was administered by intradermal route. On day 8, 0.5 mL of DPG at a concentration of 25 % (w/w) in the vehicle was applied by cutaneous route during 48 hours by means of an occlusive dressing. After a period of 12 days without treatment, a challenge cutaneous application of 0.5 mL of the vehicle (left flank) and 0.5 mL of DPG at a concentration of 25 % (w/w) in the vehicle (right flank) were administered to all animals. DPG and the vehicle were prepared on a dry gauze pad then were applied to the skin and held in place for 24 hours by means of an occlusive dressing. Cutaneous reactions on the challenge application sites were then evaluated 24 and 48 hours after removal of the dressing. After the final scoring period, the animals were killed. Due to the absence of cutaneous reactions, no skin samples were taken from the challenge application sites from all the animals. No clinical signs and no deaths were noted during this study. After 24 and 48 hours following removal of the dressing of the cutaneous challenge application of the test substance, no cutaneous reactions were recorded. The guinea-pigs showed a satisfactory sensitization response in 100 % animals using a positive sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data with a read-across substance the test item does not require classification as skin sensitizer according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.