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Diss Factsheets

Administrative data

Description of key information

In order to assess the irritancy potential of the test substance to the skin, an acute dermal irritation /corrosion toxicity study was performed in New Zealand White rabbits. Based on the results of this study, the test substance was found to be corrosive to the skin.
In accordance with column 2 of Reach Regulation (EC) No 1907/2006 Annex VIII the in-vivo eye irritation study as well as the acute inhalation toxicity study (required in section 8.2.1 and 8.5, respectively) does not need to be conducted as the test substance used for read across is corrosive to the skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Study period:
2004-02-17 to 2004-04-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well documented guideline conform, scientific GLP report. No toxicity data are available for 1-Tetradecanaminium, N,N,N-trimethyl-, methyl carbonate (CAS No. 126437-91-0, target substance) which is used as precursor for the N,N,N-trimethyltetradecan-1-aminium oxalate (CAS No. 154858-16-9, source substance). As the chemical structure of both chemicals is almost similar with the exception of the methyl carbonate anion for the target substance instead of the oxalate, read across is made to the source substance. The available studies from the source substance are sufficient to provide toxicological information of the target substance (refer to IUCLID point 13, Assessment reports.001- Read across justification).
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g test item pasted with 0.4 mL deionized water
Duration of treatment / exposure:
3 minutes (left front flank)
1 hour (left hind flank)
Observation period:
30 -60 minutes, 24, 48, 72 hours and 7, 14, and 21 days after patch removal
Number of animals:
one
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft), covered with semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water
- Time after start of exposure: 3 minutes and 1 hour

SCORING SYSTEM: DRAIZE
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: 3 minute exposure
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 72 hours
Score:
2.17
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: 1 hour exposure

Table: Summary Skin irritation results:

Duration Treatment: 3 minutes (left front flank)

Female #281

Time after Treatment

Erythema

Edema

 

30-60 min

0

0

 

24 hrs

0

0

 

48 hrs

0

0

 

72 hrs

0

0

Duration Treatment: 1 hour (left hind flank)

Female #281

Time after Treatment

Erythema

Edema

 

30-60 min

1

0

 

24 hrs

2

2

 

48 hrs

2

2

 

72 hrs

3

2

 

7 days

3

2

 

14 days

2

0

 

21 day

2

0
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this OECD 404 study the test substance is corrosive to skin (causes burns).
Executive summary:

In order to test the skin irritation/corrosive properties of the test item, an OECD 404 test was performed with New Zealand White rabbits. 24 hours prior to treatment the hair of the dorsal region of the body of one rabbit was removed with an electric clipper over an area of about 25 cm2. One animal was treated sequentially with each 0.5 g of the test substance pasted with 0.4 mL deionized water for exposure periods of 3 minutes (left front flank) and 1 hour (left hind flank). The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area, and for the 1 hour exposure, covered with a semiocclusive bandage. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin areas took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because of persistent irritations 72 hours after removal of the patch, additional readings were performed after 7, 14 and 21 days. Because of corrosion after treatment for 1 hour no further animals were used.

The results were evaluated numerical according to the score of DRAIZE. After the 3 minutes exposure period, no signs of irritations were observed during the study. After the 1 hour exposure period the following observations were described: 30 - 60 minutes up to 21 days after removal of the patches the treated skin of the animal showed very slight up to moderate or severe erythema and slight edema. Additionally, encrusted skin, coarse scales, as well as dry, rough and parchment-like skin surface were observed. 21 days after removal of the patch, the irritations had not disappeared and scar formation was noted in the skin indicating irreversible skin damage.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In order to assess the irritancy potential of the test substance to the skin, an acute dermal irritation /corrosion toxicity study was performed in New Zealand White rabbits with an analogue substance (refer to IUCLID point 13, Assessment reports.001- Read across justification). One animal was treated sequentially with each 0.5 g moistened Dodigen 5356 AS for exposure periods of 3 minutes and 1 hour. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin areas took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because of persistent irritations 72 hours after removal of the patch, additional readings were performed after 7, 14 and 21 days. Because of corrosion after treatment for 1 hour no further animals were used. Based on the results of this study, the test substance was found to be corrosive to the skin.

As the test substance is corrosive to the skin it is assumed that the substance is also corrosive to the eye and no test was performed on animal welfare reasons.With regard to inhalation toxicity of the test item no animal study was performed. This is well-founded as inhalation is no endpoint of concern and since inhalation is no critical route of exposure and no peak exposures are to be expected.

 


Justification for selection of skin irritation / corrosion endpoint:
Well documented guideline conform, scientific GLP report. No toxicity data are available for 1-Tetradecanaminium, N,N,N-trimethyl-, methyl carbonate (CAS No. 126437-91-0, target substance) which is used as precursor for the N,N,N-trimethyltetradecan-1-aminium oxalate (CAS No. 154858-16-9, source substance). As the chemical structure of both chemicals is almost similar with the exception of the methyl carbonate anion for the target substance instead of the oxalate, read across is made to the source substance. The available studies from the source substance are sufficient to provide toxicological information of the target substance (refer to IUCLID point 13, Assessment reports.001- Read across justification).

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

The test substance was found to be corrosive in an in vivo skin irritation/corrosion test acc. to OECD 404. According to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council, 16 December 2008 (CLP or GHS (Global Harmonized System for classification, labeling and packaging) Annex 1, Chapter 3.2.2.6.3 the test substance has to be classified: "Skin Corr. Cat 1B (exposition > 3 minutes ≤ 4 hour; observation time ≤14 days), H314: causes severe skin burns and eye damage".