Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Jul - 16 Aug 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted Feb 1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
EC Number:
306-227-4
EC Name:
Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
Cas Number:
96690-34-5
Molecular formula:
C4H11O4P to C8H20O7P2 as representative molecular formula of the composition as specified in section 1.2
IUPAC Name:
Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 240 - 277 g (males); 215 - 231 g (females)
- Housing: The initial two animals were housed individually throughout the study. The further group of eight animals (four male and four female) were housed individually during the 24-hour exposure period and in groups of four, by sex, for the remainder of the study.
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 Jul 2017 To: 16 Aug 2017

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 6 cm² clipped skin of the dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: the test material was held in contact with the skin with surgical gauze and a piece of self adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with cotton wool moistened with arachis oil BP
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 30 min, 1, 2 and 4 h after dosing and subsequently once daily for 14 days. Body weights were recorded prior to treatment and on Day 7 and 14 after dosing.
- Necropsy of survivors performed: Yes, all animals were subjected to gross necropsy.
- Other examinations performed: After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary irritation and scored according to Draize scoring system.

Results and discussion

Preliminary study:
One male and one female rat were initially treated with the test item at a dose level of 2000 mg/kg bw. As no mortalities were noted a further group of animals (four males and four females) was similarly treated with the test item at a dose level of 2000 mg/kg bw to give a total of five males and five females.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
All animals showed expected gains in body weight except one female animal that showed no body weight gain in the first week but an expected gain in body weight in the second week.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
- Primary irritation: Signs of dermal irritation included very slight to well defined erythema, slight edema, scattered areas of green necrosis, scattered areas of blanching, small scattered superficial scabs, hardened light and dark brown colored scabs, scab cracking, scab lifting to reveal glossy skin, dried blood and/or bleeding, crust formation and desquamation. Adverse dermal reactions prevented the accurate evaluation of erythema and edema at the treatment sites of two male and two female animals.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified