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Administrative data

Description of key information

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 based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
A read-across approach is applied between Reaction products of monoethanolamine and boric acid (1:1) and Reaction products of monoethanolamine and boric acid (1:3) for the human health endpoints due to the structural similarity of the two reaction products (Scenario 6 in ECHA’s RAAF document), both resulting from the same starting materials (only the ratio is different), and through the same manufacturing process.
Commercial MEA Polyborate products are commonly formulated at either 1:1 or 1:3 mole ratios of MEA to boric acid, or sometimes at ratios in between. All compositions in this range contain equilibrium mixtures of the exact same chemical species, but with somewhat different population distributions.
The existing physico-chemical, toxicological, environmental fate and ecotoxicological data already showed good correlation with no significant differences between the two ratios.

The results of the newly commissioned, additional anchoring studies (water solubility, vapour pressure and octanol-water coefficient, Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assays, acute toxicity studies via dermal route and oral route) showed good correlation between Reaction products of monoethanolamine and boric acid (1:1) and Reaction products of monoethanolamine and boric acid (1:3), and therefore further supported our category hypothesis.

Based on the skin sensitization study of MEA Polyborate 1:3 in the Guinea Pig, no classification as a skin sensitizer is required for MEA Polyborate 1:3. MEA Polyborate 1:3 was tested in a Magnusson and Kligman skin sensitization study in the Guinea Pig that consisted of 10 female test animals and 5 female control animals. Paired 0.1 ml intradermal injections of 4% m/v MEA Polyborate 1:3 135 g/L in water was used for the intradermal induction phase, 0.5 ml of undiluted MEA Polyborate 1:3 g/L was used for the topical application induction phase and Finn chambers containing 0.3% and 0.1% m/m MEA Polyborate 1:3 g/L in water was used for the challenge phase. Dermal responses to challenge were assessed at 24 and 48 hours after removal of the chambers. One animal developed an equivocal reaction following challenge application. Nine of the test animals showed no reactions, indicating that MEA Polyborate 1:3 is not a sensitizer (Covance 1998c).
The conclusions discussed above suggest similar local toxicity profiles for the two substances. The use of data from MEA Polyborate 1:3 to read-across to MEA Polyborate 1:1 for the skin sensitization endpoint is considered to provide sufficient confidence.
On this basis MEA Polyborate 1:1 is not considered to be a senzitizing.
Category: MEA Polyborates
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.3%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.3%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
not measured/tested
Group:
negative control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
It was concluded that MEA Polyborate 1:3 was practically devoid of potential to cause sensitisation. Based on the justification provided in the field 'Justification for type of information', this result is applicable for MEA Polyborate 1:1.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

It was concluded that MEA Polyborate 1:3 135 g/L was practically devoid of potential to cause sensitisation in an OECD 406 Skin Sensitisation study. This result is considered relevant for Reaction products of monoethanolamine and boric acid 1:1 based on the justification elaborated in the endpoint study record and the Category Justification Document. Therefore the substance is not classified for skin sensitisation under GHS.