Triethyl borate

Endpoint summary

Description of key information

An OECD Guide-line 406 "Skin Sensitisation" method  (Buehler test ) was performed using 95 % w/w boric acid moistened with distilled water to enhance skin contact. Very faint erythema was observed in one animal at induction stage and 2 animals at challenge stage and also in one naïve control.  No other adverse effects were observed therefore the test substance was considered a non-sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

OECD Guide-line 406 "Skin Sensitisation" method (Buehler test ) was performed before the LLNA was set as preferred test method.

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Davidson’s Mill Farms, South Brunswick, NJ
- Age at study initiation: Young adult
- Weight at study initiation: Males: 314 -411 g; females: 282-376 g

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Induction: 0.4 g 95 % w/w boric acid
Challenge: 95 % w/w boric acid

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Induction: 0.4 g 95 % w/w boric acid
Challenge: 95 % w/w boric acid

No. of animals per dose:

Test Group: 20 animals
Naive Control: 10 animals
Positive Control: 20 animals
Positive Naive Control: 10 animals

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Concentrations: 0.4 g 95 % w/w boric acid moistened with distilled water to enhance skin contact.


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: Test substance was wiped off with water after 6 h.

Challenge controls:

No data

Positive control substance(s):

yes

Remarks:

Dinitrochlorobenzene

Positive control results:

No data

Reading:

1st reading

Hours after challenge:

34

Group:

test chemical

Dose level:

0.4 g 95% w/w/boric acid

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Very faint erythema seen in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effect observed

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 34.0. Group: test group. Dose level: 0.4 g 95% w/w/boric acid . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Very faint erythema seen in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effect observed.

Observations:

Treatments	Buehler test	Observations/Remarks
	Day of treatment
Induction 1	day 0	Very faint erythema (0.5) observed at one test site at 24 hours after first induction dose. No other irritation observed
Induction 2	7	No irritation observed
Induction 3	14	No irritation observed
Challenge	28	No irritation observed
Scoring 1	29	Very faint erythema (0.5) observed at two test sites at 24 hours after  challenge dose. Irritation persisted at one site for 48 hours.  Very faint erythema (0.5) observed at one test site at 24 hours in one naive control.
Scoring 2	30

Results of skin sensitisation test:

	Number of animals with signs of allergic reactions / number of animals in group
	Negative control	Test group	Positive control
scored after 24h	0 / 10	0 / 20	10/20
scored after 48h	0 / 10	0 / 20	7/20

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

OECD Guide-line 406 "Skin Sensitisation" method (Buehler test ) was performed using 95 % w/w boric acid moistened with distilled water to enhance skin contact. Very faint erythema was observed in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effects were observed therefore the test substance was considered a non-sensitiser.

Reference 2

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

Reason / purpose for cross-reference:

reference to other study

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Justification for classification or non-classification

Boric acid is not a skin sensitiser. In accordance with the criteria of EU CLP Regulation (EC) No. 1272/2008) boric acid does not need to be classified and labelled as sensitizer.