Registration Dossier
Registration Dossier
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EC number: 939-512-2 | CAS number: 85681-55-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-09-10 to 1997-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
- EC Number:
- 939-512-2
- Cas Number:
- 85681-55-6
- Molecular formula:
- Not applicable for UVCB
- IUPAC Name:
- Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): LATHANOL LAL
- Purity: 100 % (UVCB)
- Lot/batch No.: Lot #7-20041
- Substance type: white powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabitry, Gary, Indiana
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 2.01 - 2.38 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))
IN-LIFE DATES: From: 1997-09-10 To: 1997-10-24
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: moistened with water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30% total body area shaved
- % coverage: 10% total body surface
- Type of wrap if used: Plastic sheeting secured with non-irritating Kendall Curity Satndard Porus tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg
- Concentration (if solution): Not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 2 g/kg
- No. of animals per sex per dose:
- 5 male/5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently on day of dosing (1, 2.5 and 4 hours) and once daily thereafter; bodyweights on study initiation, at 7 and 14 days post-administration and at death.
- Necropsy of survivors performed: yes - Statistics:
- Calculations of the LC50 and 95% confidence limits: Method of moving averages, Weil CC (1952) table for convenient calculations of median effective dose (LD50 and ED50) and instruction in their use. Biometrics, 8.
Results and discussion
- Preliminary study:
- Not performed
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 4/10 rabbits (3 male/1 female) died by Day 5 of the post-administration period. The remaining rabbits dosed with the test material survived until Day 14 of the post-administration period.
- Clinical signs:
- other: Pharmacotoxic observations were limited to the skin at the application sites and included oedema, erythema, chemical burns, scar tissue, coriaceousness and eschar. Effects were reversible by the 14 day observation period in only two animals (1 male/1 fema
- Gross pathology:
- External observations: severe tissue damage and necrosis
Internal observations: stomach devoid of contents.
Any other information on results incl. tables
Table 1: Body weight gain
Rabbit Number |
Sex |
Initial Bwt (kg) |
7 day Bwt (kg) |
14 day Bwt (kg) |
258 |
F |
2.02 |
1.97 |
2.13 |
259 |
F |
2.04 |
- |
- |
260 |
F |
2.30 |
2.35 |
2.43 |
261 |
F |
2.22 |
2.24 |
2.52 |
262 |
F |
2.14 |
1.94 |
2.05 |
274 |
M |
2.19 |
2.32 |
2.59 |
275 |
M |
2.02 |
- |
- |
276 |
M |
2.01 |
1.89 |
2.06 |
277 |
M |
2.38 |
- |
- |
278 |
M |
2.20 |
- |
- |
Table 2: clinical observations
Rabbit Number |
Sex |
Observation period |
||||||||||||||||
|
|
1h |
2.5h |
4h |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
Day 7 |
Day 8 |
Day 9 |
Day 10 |
Day 11 |
Day 12 |
Day 13 |
Day 14 |
258 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
OQ |
OQ |
OQ |
Q |
Q |
Q |
259 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
X |
|
|
|
|
|
|
|
|
|
|
260 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
O |
OQ |
OQ |
Q |
Q |
261 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
MO |
O |
O |
O |
√ |
√ |
262 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
MO |
O |
O |
OQ |
OQ |
274 |
M |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
MO |
O |
O |
O |
√ |
√ |
275 |
M |
√ |
√ |
√ |
LMP |
LMOP |
LMOP |
X |
|
|
|
|
|
|
|
|
|
|
276 |
M |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
MO |
MO |
MO |
O |
OQ |
OQ |
277 |
M |
√ |
√ |
√ |
LMP |
LMOP |
LMOP |
X |
|
|
|
|
|
|
|
|
|
|
278 |
M |
√ |
√ |
√ |
LMP |
LMOP |
LMOP |
LMOP |
X |
|
|
|
|
|
|
|
|
|
√ - Normal
X - Dead
L - Erythema
M - Oedema
O – Eschar and coriaceousness
P – Chemical burns
Q – Scar tissue
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal administration of the test material (2 g/kg bw) resulted in an LD50 > 2000 mg/kg bw.
- Executive summary:
In this study, performed in accordance with OECD TG 402 under GLP, the substance, moistened with water, was applied to the shaved skin of rabbits (five/sex) at a dose of 2000 mg/kg bw under occlusive conditions for 24 hours. Four animals died during the 14-day observation period. No treatment related effects were noted on bodyweight gain in the remaining animals. Observations noted during the study were limited to the skin at the application sites and included erythema, edema, chemical burns, scar tissue, coriaceousness and eschar. At necropsy external observations included severe tissue damage and necrosis of skin at the application site of all four animals that died prematurely and scar tissue/scar tissue and eschar in four of the surviving animals. Two animals showed no external changes. Internally, two of the animals that died prematurely had empty stomachs. The remaining animals showed no gross internal changes. The LD50 was > 2000 mg/kg bw.
In accordance with Regulation (EC) No. 1272/2008 the substance is not classified for acute toxicity by the dermal route.
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