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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt
EC Number:
286-344-4
EC Name:
2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt
Cas Number:
85209-91-2
Molecular formula:
C29H43O4P.Na
IUPAC Name:
sodium 5,7,13,15-tetra-tert-butyl-10-oxo-9,11-dioxa-10λ⁵-phosphatricyclo[10.4.0.0³,⁸]hexadeca-1(12),3,5,7,13,15-hexaen-10-olate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Sprague-Dawley origin (Hsd:Sprague-Dawley (CD))
- Source: Harlan U.K. Ltd., Bicester, Oxon, England.
- Age at study initiation: 8 - 11 weeks
- Weight at study initiation: 221 - 260 g
- Housing: individually in metal cages (RS Biotech Sub-Dividable Rodent Cages - polished stainless steel) until Day 4 when they were returned to group housing. Cages fitted with grid floors.
- Diet (e.g. ad libitum): standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet)
- Water (e.g. ad libitum): drinking water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 48% aqueous methycellulose
Details on dermal exposure:
dorso-lumbar region
- Area of exposure: approximately 50 mm x 50 mm
- % coverage: 10
- Type of wrap if used: waterproof dressing (encircled firmly around the trunk of the animal)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30-40°C), blotted dry with absorbent paper
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution):48% w/v
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 4,17 ml
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 rats (5 of each sex)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation of clinical signs after dosing, at frequent intervals of this day 1, day 2-14 twice daily,
day 15 in the morning, local dermal irritation daily observed
weighing day 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: local dermal irritation (erythema, eschar formation, oedema formation), any other lesion or reaction (spots, scabbing)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: none
Gross pathology:
no abnormalities
Other findings:
dermal reactions: very slight dermal irritation (erythema and/or oedema), resolving completely on day 4. Scabbing and/or spots in 3 females on day 6, resolving completely by day 7, 9, 11.

Applicant's summary and conclusion

Interpretation of results:
other: LD50 > 2000 mg/kg
Conclusions:
No labelling regarding acute dermal toxicity according to Regulation (EC) No 1272/2008 is required.