Reaction products of monoethanolamine and boric acid (1:3)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Full study but only available as a letter report.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Guinea pig test was already available.

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

No data

Route:

intradermal

Vehicle:

water

Concentration / amount:

0.1 and 0.3% liquid boron in water

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

0.1 and 0.3% liquid boron in water

No. of animals per dose:

10

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Site: Dorsum overlying the scapulae
- Frequency of applications: Once
- Concentrations: 0.1 ml per site

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 and 48 hours
- Site: Right flank
- Concentrations: 0.3. 0.1% liquid boron in water
- Evaluation (hr after challenge): 24 and 48 hours

Positive control substance(s):

not specified

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

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 chemical

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 chemical

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 chemical

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 1:3 135 g/L was practically devoid of potential to cause sensitisation.

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. Therefore, the substance is not classified for skin sensitisation under GHS.