Tris(2-butoxyethyl) phosphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Adequacy of study:

supporting study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short report of guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Method: other: CFR Part 191.1, Chapter 1, Title 21

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Route of administration:

oral: gavage

Doses:

2150 and 4640 mg/kg bw

No. of animals per sex per dose:

5

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 4 640 mg/kg bw

There were no deaths among the rats exposed to test material at 2150 mg/kg bodyweight. At 4640 mg/kg bwt 3/5 rats died. No clinical signs were reported in rats exposed to 2150mg/kg bwt. No abnormalities were noted in survivors at necropsy.

Interpretation of results:

Category 5 based on GHS criteria

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well reported study; in line with OECD 405/EC B5

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Method: other: Code of Federal Regulations Part 191.12, Chap.1, Title 21

Species:

rabbit

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Number of animals or in vitro replicates:

6

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

0

Three of six rabbits showed no signs of irritation. Three rabbits exhibited moderate conjunctival erythema and iritis which resolved within 48-h.

Interpretation of results:

GHS criteria not met

Conclusions:

TBEP is not classified for eye irritation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize Test

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-butoxyethyl) phosphate

EC Number:

201-122-9

EC Name:

Tris(2-butoxyethyl) phosphate

Cas Number:

78-51-3

Molecular formula:

C18H39O7P

IUPAC Name:

tris(2-butoxyethyl) phosphate

Details on test material:

Phosflex T-BEP

Test animals

Species:

rabbit

Test system

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Time point:

24/48/72 h

Score:

3.17

Remarks on result:

other: observation at 24h and 72h

Results 2

Irritation parameter:

other: PDII for intact sites only

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.42

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: obseravtion at 24h and 72h

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.57

Max. score:

4

Remarks on result:

other: abraded skin

Remarks:

observation at 24h and 72h

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.09

Max. score:

4

Remarks on result:

other: intact skin

Remarks:

observation at 24h and 72h

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Remarks on result:

other: intact skin

Remarks:

observation at 24h and 72h

Any other information on results incl. tables

Erythema was more severe in abraded than intact sites at both 24 and 72-h. There was only a single rabbit (female) with oedema of an intact site (score 1) at 72-h. All abraded sites were scored for oedema at 24-h (mean score = 2); 2/6 abraded sites had resolved by 72-h - mean oedema score at 72-h was 1.13. The aggregate score for erythema at 24 and 72-h were 1.66 and 1.0 respectively for the intact sites. The mean scores for oedema of intact sites at 24 and 72-h were: 0 and 0.17 respectively.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

TBEP was considered a moderate irritant by US FDA criteria. However, from the lower scores recorded at intact sItes than abraded site, TBEP would not be classified for skin irritation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.