2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2) obtained from a solvent-based manufacturing process is not isolated throughout the process. The solvent-free N 8424-2 is a solid which would significantly complicate the manufacturing process. Beyond that N 8424-2 is not marketed as such. At the end of the process a blend of 53 weight-% N 8424-2 and 47 weight-% of a corresponding PO adduct of the alkylene oxide reactive solvent are dissolved in Tris(chloroisopropyl) phosphate (TCPP) to facilitate handling of the substance by downstream users and to improve the flame-retardant action. 70% of the blend (N 8424-2 and corresponding PO adduct of the alkylene oxide reactive solvent) and 30% TCPP represent the commercial product for which a base set of toxicological information was already available. Further, analysis of the toxicity profile of the solvents in the commercial product demonstrates that the available studies with the commercial product, which contains 37% N 8424-2 (0.7 x 53%), is sufficient for an adequate hazard characterisation of N 8424-2.

Justification for type of information:

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2) obtained from a solvent-based manufacturing process is not isolated throughout the process. The solvent-free N 8424-2 is a solid which would significantly complicate the manufacturing process. Beyond that N 8424-2 is not marketed as such. At the end of the process a blend of 53 weight-% N 8424-2 and 47 weight-% of a corresponding PO adduct of the alkylene oxide reactive solvent are dissolved in Tris(chloroisopropyl) phosphate (TCPP) to facilitate handling of the substance by downstream users and to improve the flame-retardant action. 70% of the blend (N 8424-2 and corresponding PO adduct of the alkylene oxide reactive solvent) and 30% TCPP represent the commercial product for which a base set of toxicological information was already available. Further, analysis of the toxicity profile of the solvents in the commercial product demonstrates that the available studies with the commercial product, which contains 37% N 8424-2 (0.7 x 53%), is sufficient for an adequate hazard characterisation of N 8424-2.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no pathology reported

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

8-9 weeks of age.
Housed in single sex groups of five rats to a cage with free access to drinking water and food throughout the study.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The rats were fasted vernight, weighed and given a single dose using a ball pointed cannula and syringe. Approx. three hours after dosing on Day 1 the animals were allowed food again ad libitum.

Doses:

females: 1020, 1430, 2000 and 2800 mg/kg bw single dose
males: 2000, 2800, 3920 and 5490 mg/kg bw single dose

No. of animals per sex per dose:

five

Control animals:

no

Details on study design:

Clinical examination was made three times daily for the first three days and once daily thereafter for the remainder of the 14 day observation period. The initial, day 7 and day 14 bw were recorded, and changes in bw calculated. The study was terminated on day 14. One animal was retained until day 28 to ascertain if it recovered completely from effects of treatment that persisted to day 14.

Statistics:

the 14 day LD50, 95% confidence interval and the dose-mortality slope were calculated using a method based on probit analysis.

Sex:

female

Dose descriptor:

LD50

Effect level:

1 977 mg/kg bw

Based on:

test mat.

95% CL:

1 676 - 2 236

Remarks on result:

other: >= 1020 mg/kg bw 5/5 animals with toxic signs

Sex:

female

Dose descriptor:

LD50

Effect level:

732 mg/kg bw

Based on:

other: 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether

Sex:

male

Dose descriptor:

LD50

Effect level:

4 359 mg/kg bw

Based on:

test mat.

95% CL:

3 561 - 5 779

Remarks on result:

other: >= 2000 mg/kg bw 5/5 animals with toxic signs

Sex:

male

Dose descriptor:

LD50

Effect level:

1 613 mg/kg bw

Based on:

other: 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether

Mortality:

Mortalities occurred on days 2, 3 and in one case on day 7.

Clinical signs:

other: Lethargy, salivation, abasia/ataxia and hunched back were observed among rats at all dose-levels within three hours of dosing. Other common reactions were: - diarrhoea among all rats from dose levels from day 2 - unkepmpt appearnce among rats from all do

Gross pathology:

no data available

Table 1: Acute oral toxicity of FOX-O-POL VD 280 S

Sex	dose (mg/kg bw)	Toxicological results	Onset and duration of signs	Onset of mortality
male	2000	0 / 5/ 5	3h - 7d	---
	2800	0 / 5 / 5	3h - 7d	---
	3920	2 / 5 / 5	0.5h - 11d	1d-7d
	5490	4/ 5 / 5	0.5h - 27d	2d-3d
female	1020	0 / 5 / 5	1h - 4d	---
	1430	0 / 5 / 5	0.5h - 12d	---
	2000	3 / 5 / 5	3h - 7d	3d
	2800	5 / 5 / 5	3h - ---	2d - 3d

Toxicological results:

number of dead animals / number of animals with signs after cessation of exposure / number of animals exposed

Table 2: Acute oral toxicity of 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2)calculated from the acute oral study of FOX-O-POL VD 280 S (commercial product)

 

Sex	Dose [mg/kg]	Toxicological result	Onset and duration of diarrhea	Onset of mortality
males	2031	4 / 2 / 5	2d – 9d	2d (2 males) 3d (2 males)
males	1450	2 / 3 / 5	2d – 9d	2d (1 male) 7d (1 male)
males	1036	0 / 5 / 5	2d – 4d
females	1036	5 / 0 / 5		2d (3 females) 3d (2 females)
males	740	0 / 5 / 5	2d – 4d	---
females	740	3 / 4 / 5	2d - 4d	---3d
females	529	0 / 5 / 5	2d - 4d	---
females	377	0 / 1 / 5	2d - 3d	---

 

Toxicological results:

number of dead animals / number of animals with diarrhoe / number of animals exposed

 

Executive summary:

The LD50 for 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether was thus calculated to be approx. 732 mg/kg bw based on the the LD50 = 1977 mg/kg (female rat) of the commercial product which was determined according to OECD TG 401 (Gardner, 1989). Groups of five male and five female rats were dosed with the undiluted test material by gavage. Rats of all dose levels showed unkempt appearance first apparent at intervals from within 1.5 hours after dosing to day 2 and diarrhoe from day 2. From the mortality data the LD50 -values were calculated to be 4359 mg/kg (male) and 1977 mg/kg (female).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

732 mg/kg bw

Quality of whole database:

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2) obtained from a solvent-based manufacturing process is not isolated throughout the process. The solvent-free N 8424-2 is a solid which would significantly complicate the manufacturing process. Beyond that N 8424-2 is not marketed as such. At the end of the process a blend of 53 weight-% N 8424-2 and 47 weight-% of a corresponding PO adduct of the alkylene oxide reactive solvent are dissolved in Tris(chloroisopropyl) phosphate (TCPP) to facilitate handling of the substance by downstream users and to improve the flame-retardant action. 70% of the blend (N 8424-2 and corresponding PO adduct of the alkylene oxide reactive solvent) and 30% TCPP represent the commercial product for which a base set of toxicological information was already available. Further, analysis of the toxicity profile of the solvents in the commercial product demonstrates that the available studies with the commercial product, which contains 37% N 8424-2 (0.7 x 53%), is sufficient for an adequate hazard characterisation of N 8424-2.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2) obtained from a solvent-based manufacturing process is not isolated throughout the process. The solvent-free N 8424-2 is a solid which would significantly complicate the manufacturing process. Beyond that N 8424-2 is not marketed as such. At the end of the process a blend of 53 weight-% N 8424-2 and 47 weight-% of a corresponding PO adduct of the alkylene oxide reactive solvent are dissolved in Tris(chloroisopropyl) phosphate (TCPP) to facilitate handling of the substance by downstream users and to improve the flame-retardant action. 70% of the blend (N 8424-2 and corresponding PO adduct of the alkylene oxide reactive solvent) and 30% TCPP represent the commercial product for which a base set of toxicological information was already available. Further, analysis of the toxicity profile of the solvents in the commercial product demonstrates that the available studies with the commercial product, which contains 37% N 8424-2 (0.7 x 53%), is sufficient for an adequate hazard characterisation of N 8424-2.

Justification for type of information:

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2) obtained from a solvent-based manufacturing process is not isolated throughout the process. The solvent-free N 8424-2 is a solid which would significantly complicate the manufacturing process. Beyond that N 8424-2 is not marketed as such. At the end of the process a blend of 53 weight-% N 8424-2 and 47 weight-% of a corresponding PO adduct of the alkylene oxide reactive solvent are dissolved in Tris(chloroisopropyl) phosphate (TCPP) to facilitate handling of the substance by downstream users and to improve the flame-retardant action. 70% of the blend (N 8424-2 and corresponding PO adduct of the alkylene oxide reactive solvent) and 30% TCPP represent the commercial product for which a base set of toxicological information was already available. Further, analysis of the toxicity profile of the solvents in the commercial product demonstrates that the available studies with the commercial product, which contains 37% N 8424-2 (0.7 x 53%), is sufficient for an adequate hazard characterisation of N 8424-2.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

no pathology reported

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS:
- Source: charles River U.K. Ltd.
- Age: 8 to 9 weeks
- Weight at study initiation: > 200 g (male); > 130 g (female)
- Group size: individually housed druring exposure;for the post exposure period the animals returned to group housing

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

ADMINISTRATION:
- Area covered: approx. 6 x 8 cm
- Occlusion: lint dressing covered with waterproof adhesive tape
- Total volume applied: not specified
- Removal of test substance: the dressings were removed, the skin washed with warm dilute detergent solution, dried, and the animals returned to group housing.

Duration of exposure:

24 hours

Doses:

single dose: 2000 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

EXAMINATIONS:
A careful clinical examination was made three times daily for the first three days and once daily thereafter for the remainder of the 14 day observation period. The initial (day 1), day 7 and day 14 bodyweights were recorded, and changes in bodyweight calculated. The study was terminated on day 14.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: without any effect

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 740 mg/kg bw

Based on:

other: approx. 37% 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether

Mortality:

There were no deaths during the study.

Clinical signs:

other: No signs of systemic toxicity.

Gross pathology:

No data available

Other findings:

Sites of application showed no dermal changes or other irritation reaction.

As displayed in table 1 the comparison of the toxicilogical data available for the commerial product and for some constituents showed that the commercial product is suitable as surrogate for  2,2',6,6'-Tetrabromo-4,4'-iso-propylidene-diphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2)

Table 1 Base set of toxicological data with regard to the commercial product as surrogate for 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2)

Target Substance	Acute oral [mg/kg]	Acute dermal [mg/kg]	Local irritation	Skin sensitization	Ames-Test
Commercial Product (mixture of A + B +C)	LD50: 1977     C & L: Cat 4	LD50: > 2000     C & L: no category	Skin: no irritation Eye: slight irritation   C & L: no category	Negative     C & L: no category	Negative
A: a corresponding PO adduct of the alkylene oxide reactive solvent	LD50: > 2000    C & L: no category	LD50: > 2000     C & L: no category	Skin: no irritation Eye: no irritation   C & L: no category	Negative     C & L: no category	Negative
B: Tris(chloroisopropyl) phosphate	500 > LD50< 2000   C & L: Cat 4	LD50: > 2000     C & L: no category	Skin: slight irritation Eye: no irritation   C & L: no category	Negative     C & L: no category	Negative
C: 2,2',6,6'-Tetrabromo- 4,4'-iso-propylidene-diphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2)	No data     C & L: Cat 4	No data       C & L: no category	No data     C & L: no category	No data      C & L: no category	No data       No evidence for induction of point mutation in bacteria

Executive summary:

The LD50 for 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether was thus calculated to be > 740 mg/kg bw based on the the LD50 > 2000 mg/kg of the commercial product which was determined according to OECD TG 402 (Gardner, 1989). 2000 mg/kg of the commercial product was applied occlusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development and local irritaion were observed during the 14 -days observation period.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2) obtained from a solvent-based manufacturing process is not isolated throughout the process. The solvent-free N 8424-2 is a solid which would significantly complicate the manufacturing process. Beyond that N 8424-2 is not marketed as such. At the end of the process a blend of 53 weight-% N 8424-2 and 47 weight-% of a corresponding PO adduct of the alkylene oxide reactive solvent are dissolved in Tris(chloroisopropyl) phosphate (TCPP) to facilitate handling of the substance by downstream users and to improve the flame-retardant action. 70% of the blend (N 8424-2 and corresponding PO adduct of the alkylene oxide reactive solvent) and 30% TCPP represent the commercial product for which a base set of toxicological information was already available. Further, analysis of the toxicity profile of the solvents in the commercial product demonstrates that the available studies with the commercial product, which contains 37% N 8424-2 (0.7 x 53%), is sufficient for an adequate hazard characterisation of N 8424-2.

Additional information

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2) obtained from a solvent-based manufacturing process is not isolated throughout the process. The solvent-free N 8424-2 is a solid which would significantly complicate the manufacturing process. Beyond that N 8424-2 is not marketed as such. At the end of the process a blend of 53 weight-% N 8424-2 and 47 weight-% of a corresponding PO adduct of the alkylene oxide reactive solvent are dissolved in Tris(chloroisopropyl) phosphate (TCPP) to facilitate handling of the substance by downstream users and to improve the flame-retardant action. 70% of the blend (N 8424-2 and corresponding PO adduct of the alkylene oxide reactive solvent) and 30% TCPP represent the commercial product for which a base set of toxicological information was already available. Further, analysis of the toxicity profile of the solvents in the commercial product demonstrates that the available studies with the commercial product, which contains 37% N 8424-2 (0.7 x 53%), is sufficient for an adequate hazard characterisation of N 8424-2.

As displayed in table 1 the comparison of the data available for the commerial product and for some constituents showed that the commercial product is suitable as surrogate for  2,2',6,6'-Tetrabromo-4,4'-iso-propylidene-diphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2).

Table 1 Base set of toxicological data with regard to the commercial product as surrogate for 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2)

Target Substance	Acute oral [mg/kg]	Acute dermal [mg/kg]	Local irritation	Skin sensitization	Ames-Test
Commercial Product (mixture of A + B +C)	LD50: 1977     C & L: Cat 4	LD50: > 2000     C & L: no category	Skin: no irritation Eye: slight irritation   C & L: no category	Negative     C & L: no category	Negative
A: a corresponding PO adduct of the alkylene oxide reactive solvent	LD50: > 2000    C & L: no category	LD50: > 2000     C & L: no category	Skin: no irritation Eye: no irritation   C & L: no category	Negative     C & L: no category	Negative
B: Tris(chloroisopropyl) phosphate	500 > LD50< 2000   C & L: Cat 4	LD50: > 2000     C & L: no category	Skin: slight irritation Eye: no irritation   C & L: no category	Negative     C & L: no category	Negative
C: 2,2',6,6'-Tetrabromo- 4,4'-iso-propylidene-diphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2)	No data     C & L: Cat 4	No data       C & L: no category	No data     C & L: no category	No data      C & L: no category	No data No evidence for induction of point mutation in bacteria

In particular the comparison (see below) of the acute oral toxicity study with the results of the dose range finding study which was conducted before starting the subacute oral study (see IUCLID Chapter 7.5.1) proves that the toxicity of the commercial product well reflects the toxicity of N 8424 -2. The dose response relationship demonstrated by clinical signs (changed feces consistency) and onset of lethality were comparable between the acute oral toxicity study and the dose range finding study thus 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether (= N 8424-2) as constituent of the commercial product behaves like the dissolved parent compound.

	Day	1	2	3	4	5	6	7	8	9	10
Single dose of the undiluted commercial product by gavage (based on the N 8424 -2 content)
males	2031 mg/kg		2/5	2/5
males	1450 mg/kg		1/5					1/5
males	1036 mg/kg		5/5		0/5
females	1036 mg/kg		3/5	2/5
males	740 mg/kg		5/5		0/5
females	740 mg/kg		4/5	3/5
females	529 mg/kg		5/5		0/5
females	377 mg/kg		1/5	0/5
Daily single dose of N 8424-2 in corn oil by gavage over 10 days
males	1000 mg/kg	0/3	3/3	3/3	3/3
males	500 mg/kg	0/3	3/3
	100 mg/kg					0/3	0/3	0/3	0/3	1/3	0/3
males	100 mg/kg	0/3	0/3
	30 mg/kg			0/3	0/3	0/3	0/3	0/3	0/3	0/3	0/3
females	1000 mg/kg	0/3	2/3	2/3	3/3
females	500 mg/kg	0/3	2/3
	100 mg/kg					1/2	1/2	0/1	0/1	1/1	0/1
females	100 mg/kg	0/3	1/3
	30 mg/kg			2/3	0/3	0/3	0/3	0/3	0/3	0/3	0/3

 

Number of animals with changed feces consistency/number of animals treated

 

 Killed in moribund condition or died after treatment - number of dead animals/ number of animals treated

 

Discontinuation of treatment

Acute toxicity: oral

The LD50 for 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether was thus calculated to be approx. 732 mg/kg bw based on the the LD50 = 1977 mg/kg (female rat) of the commercial product which was determined according to OECD TG 401 (Gardner, 1989). Groups of five male and five female rats were dosed with the undiluted test material by gavage. Rats of all dose levels showed unkempt appearance first apparent at intervals from within 1.5 hours after dosing to day 2 and diarrhoe from day 2. From the mortality data the LD50 -values were calculated to be 4359 mg/kg (male) and 1977 mg/kg (female).

Acute toxicity: Inhalation No data available

Acute toxicity: dermal

The LD50 for 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether was thus calculated to be > 740 mg/kg bw based on the the LD50 > 2000 mg/kg of the trade product which was determined according to OECD TG 402 (Gardner, 1989).2000 mg/kg of the trade product was applied occlusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development and local irritaion were observed during the 14 -days observation period.

Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Acute toxicity: oral

The LD50 was calculated to be 732 mg/kg bw (rat, female)

According to EU-Directive 67/548/EEC, Annex VI 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether shall be classified as harmful.

According to Regulation (EC) No 1272/2008, Annex I 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether shall be allocated to Category 4.

Acute toxicity: inhalation

No data available

Acute toxicity: dermal

The LD50 was calculated to be > 740 mg/kg bw (rat, female/male).

According to Regulation (EC) No 1272/2008, Annex I 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether would be allocated to Category 3 according to the numeric criteria because the calculated LD50 (> 740 mg/kg) is below 1000 mg/kg. But for the trade product neither mortality nor any clinical effect were observed and also no local irritation occurred when applying 2000 mg/kg (= limit dose) during 24 hours. Since the solid 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether may have a much lower dermal absorption rate than the liquid trade product and the fact, that only local adverse effects in the intestine were observed in the subacute oral study it is found appropriate to regard the test result of the commercial product (LD50 > 2000 mg/kg as an direct equivalent acute toxicity estimate (ATE) for I 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with Propylene oxide and n-butyl glycidyl ether which leads to:

No classification required according to EU-Directive 67/548/EEC, Annex VI.

No classification required according to Regulation (EC) No 1272/2008, Annex I.