Registration Dossier

Administrative data

Description of key information

No skin irritation was observed in an acute dermal toxicity study (2000 mg/kg body weight)
According the REACH Regulation column 2 in Annex VII “in vitro study for skin corrosion and in vivo study for skin irritation does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).”
Based on the read across to the source chemical dodecanedioic acid, which is classified as H319, causes serious eye irritation, the target chemical tridecanedioc acid is also classified as H 319.
Serious eye damage/eye irritation: The substance tridecanedioic acid is classified as H319, causes serious eye irritation. Therefore a study on eye irritation is not foreseen according to Annex VII , Chapter 8.2 , column 2.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1989-02-14 to 1989-05-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The target substance tridecanedioic acid and its analogue dodecanedioic acid are both unsubstituted linear aliphatic dicarboxylic acids differing in chain length by only one methylene (CH2) group. The functional groups of both substances are identical, namely: carboxylic acid and methylene groups. There is no difference in their arrangement in the molecular structure. The only difference between source structure and target structure is an increase in the number of methylene groups from 10 to 11. Since already 10 methylene groups are present in the source structure, no qualitative change and no significant quantitative change in chemical and biological activities is to be expected upon adding one more methylene group. It is therefore suggested that read across can be performed for complex biochemical endpoints based on the close structural similarity between dodecanedioic acid and its analogue tridecanedioic acid.
Data waiving:
other justification
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male 
- Number of animals: 6 males
- Controls: untreated eye
- Weight at study initiation: 2.1-2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14.02 1989 To: 17.05.1989
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
ADMINISTRATION/EXPOSURE 
- Concentration: undiluted
- Amount applied: 0.1 g
- Preparation of test substance: grinding in mortar
- Vehicle: none
- Postexposure observation period: 13 days
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
- Postexposure observation period: 13 days
Number of animals or in vitro replicates:
6
Details on study design:
Comment: rinsed after 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 7, 8, 10 and 13  days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.44
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72h
Score:
2.5
Reversibility:
fully reversible
Remarks on result:
other: erythema
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72h
Score:
1.06
Reversibility:
fully reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.44
- Conjunctivae (Redness): 2.50
- Conjunctivae (Chemosis): 1.06
- Overall irritation score: 11.96/110
Other effects:
REVERSIBILITY: complete within 10 days
OTHER EFFECTS: There were no indications of mechanical irritation by the  finely ground solid test material. Conglutination of eyelids was observed 
in the males at 24 or at 48 hours.

    no effects on cornea                                                                                           

Animal No

Iris, Observation time

1 h

24 h

48 h

72 h

6-13 days

57889

1

0

0

0

0

58051

1

0

0

0

0

58057

1

1

1

0

0

70115

1

1

0

0

0

70293

1

1

1

1

0

70327

1

1

1

0

0

The target substance tridecanedioic acid and its analogue dodecanedioic acid are both unsubstituted linear aliphatic dicarboxylic acids differing in chain length by only one methylene (CH2) group. The functional groups of both substances are identical, namely: carboxylic acid and methylene groups. There is no difference in their arrangement in the molecular structure. The only difference between source structure and target structure is an increase in the number of methylene groups from 10 to 11. Since already 10 methylene groups are present in the source structure, no qualitative change and no significant quantitative change in chemical and biological activities is to be expected upon adding one more methylene group. It is therefore suggested that read across can be performed for complex biochemical endpoints based on the close structural similarity between dodecanedioic acid and its analogue tridecanedioic acid.

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Conclusions:
In this study, dodecanedioic acid was an eye irritant.
Read across can be performed for complex biochemical endpoints based on the close structural similarity between dodecanedioic acid and its analogue tridecanedioic acid.
Therefore the target substance tridecanedioic acid will also be classified as an eye irritant
Executive summary:

In a primary eye irritation study 0.1 g of dodecanedioic acid was instilled into the conjunctival sac of the right eye of six male young adult White Russian rabbits. Animals then were observed for 13 days. 

Cornea were not affected. Iris was very mild and reversibly affected. Chemosis and erythema were recorded for conjunctival effects, mean score (24 -72h) was 2.5 for iridal redness. Eyes were normal with 1 - 7 days. In this study, dodecanedioic acid was an eye irritant..

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No skin irritation was observed in an acute dermal toxicity study (2000 mg/kg body weight) for tridecanedioic acid, therefore the substance is not irritating. Based on a read across to source chemical dodecanedioic acid, the substance tridecanedioic acid is classified as irritating to eyes.

The complete read across justification is attached as document.


Justification for selection of skin irritation / corrosion endpoint:
An acute dermal toxicity study was conducted according to OECD and GLP (LPT 2013), with the results of no skin irritation at the limit dose level of 2000 mg/kg bw. Therefore a skin irritation/corrosion study is waived based on the REACH Regulation column 2 in ANNEX VII “in vitro study for skin corrosion and in vivo study for skin irritation does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).”

Justification for selection of eye irritation endpoint:
The substance tridecanedioic acid is classified as H319, causes serious eye irritation, based on a read across to source chemical dodecanedioic acid.

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the available information in the dossier, the substance tridecanedioic acid (CAS No. 505-52-2) is classified for serious eye damage/eye irritation (Category 2; H319: Causes serious eye irritation) when considering the criteria outlined in Annex I of 1272/2008/EC.