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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Cross-referenceopen allclose all
Reason / purpose:
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:
reference to same study
Reason / purpose:
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
Reason / purpose:
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:
reference to same study
Reason / purpose:
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:
other: Draize Test
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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
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
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
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.