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Toxicological information

Acute Toxicity: dermal

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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:
1997
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

Constituent 1
Chemical structure
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
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

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:
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 female).
Body weight:
Body weight of all surviving animals increased up to Day 14.
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.