Dioctyltin dilaurate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

tudy conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

additional blood sampling for determination of absorption

Principles of method if other than guideline:

Blood samples for toxicokinetics (0.5 mL nominal) were taken from all animals on Day 1 at 3 and 24 hours after dosing.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dioctyltin dilaurate

EC Number:

222-883-3

EC Name:

Dioctyltin dilaurate

Cas Number:

3648-18-8

Molecular formula:

C40-H80-O4-Sn

IUPAC Name:

dioctyltin dilaurate

Test material form:

other: liquid

Details on test material:

TIB KAT 216 Ch. 020188

Test animals

Species:

rat

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

2000 mg / kg bw

No. of animals per sex per dose:

5 male and female

Control animals:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Clinical signs following treatment

Dose level: 2000 mg/kg

Clinical sign	Animal number and sex
	29M	30M	31M	32M	33M
No observations	ü	ü	ü	ü	ü

 

Clinical sign	Animal number and sex
	34F	35F	36F	37F	38F
No observations	ü	ü	ü	ü	ü

 

Dermal reactions

Dose level: 2000 mg/kg

Day	Dermal reaction	Animal number and sex
		29M	30M	31M	32M	33M
2 to 15	Erythema Oedema Other	0 0 -	0 0 -	0 0 -	0 0 -	0 0 -

 

Day	Dermal reaction	Animal number and sex
		34F	35F	36F	37F	38F
2 to 15	Erythema Oedema Other	0 0 -	0 0 -	0 0 -	0 0 -	0 0 -

Individual body weights and weekly increments

Dose level (mg/kg)	Animal number and sex	Body weight (g) at:					Increment (g)
		Day -1	Day 1	Day 4	Day 8	Day 15	Day 1 to 8	Day 8 to 15
2000	29M	257	266	273	279	308	13	29
	30M	260	269	269	279	294	10	15
	31M	279	286	284	289	307	3	18
	32M	268	271	272	281	294	10	13
	33M	269	281	283	293	306	12	13
2000	34F	181	188	195	189	203	1	14
	35F	201	207	203	213	216	6	3
	36F	180	183	179	190	202	7	12
	37F	178	186	178	191	200	5	9
	38F	195	202	202	210	222	8	12

Necropsy findings

Dose level:2000 mg/kg

Animal number and sex	Time and manner of death (Day)	Necropsy comments
29M	15T	No macroscopic changes
30M	15T	No macroscopic changes
31M	15T	No macroscopic changes
32M	15T	No macroscopic changes
33M	15T	No macroscopic changes
34F	15T	No macroscopic changes
35F	15T	No macroscopic changes
36F	15T	Liver: raised area, right median lobe - 9 mm diameter           raised area protruding into thoracic cavity - moderate #
37F	15T	No macroscopic changes
38F	15T	No macroscopic changes

 

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute median lethal dermal dose of TIB KAT 216 to rats was found to exceed 2000 mg/kg.